Trial Outcomes & Findings for A Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06700841, With Bioavailability/Food Effect Investigation (NCT NCT02310750)
NCT ID: NCT02310750
Last Updated: 2017-03-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
96 participants
Primary outcome timeframe
Baseline, 24 hours post-dose on Day 1
Results posted on
2017-03-08
Participant Flow
Study conducted in 7 Healthy Participant (HP) cohorts: 6 cohorts included Single Ascending Dose (SAD), 4 which continued into Multiple Ascending Dose (MAD) with washout, and a final cohort was tested for food effect (fasted/fed) with washout. 1 multiple dose (MD) cohort in Psoriasis subjects received drug at 2 different dose levels or placebo.
Participant milestones
| Measure |
PF--06700841: 1 Milligram (mg) SAD Cohort
Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF--06700841: 3 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF--06700841: 10 mg SAD Cohort Then MAD Cohort
Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 10 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
|
PF-06700841: 30 mg SAD Cohort Then MAD Cohort
Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 30 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
|
PF--06700841: 100 mg SAD, 100 mg MAD, 50 mg MAD Cohort
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 100 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days, then PF-06700841 tablet 50 mg orally, twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
|
PF--06700841: 200 mg SAD Cohort, 175 mg MAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 175 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
|
Placebo: SAD Cohort Then MAD Cohort
Healthy participants received placebo matched to PF-06700841 single tablet orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then placebo matched to PF-06700841 tablet once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days followed by placebo matched to PF-06700841 tablet twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tablet Fasted, Tablet Fed, Solution Fasted
Participants received PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 2 (9 days) followed by second washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
|
PF-06700841: 100 mg Solution Fasted, Tablet Fasted, Tablet Fed
Participants received PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
|
PF-06700841: 100 mg Tablet Fed, Solution Fasted, Tablet Fasted
Participants received PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
|
PF-06700841: 100 mg Tablet Fasted, Solution Fasted, Tablet Fed
Participants received PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
|
PF-06700841: 100 mg Solution Fasted, Tablet Fed, Tablet Fasted
Participants received PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
|
PF-06700841: 100 mg Tablet Fed, Tablet Fasted, Solution Fasted
Participants received PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HP Period 1
STARTED
|
7
|
6
|
6
|
6
|
8
|
8
|
13
|
0
|
0
|
0
|
2
|
2
|
2
|
2
|
2
|
2
|
|
HP Period 1
COMPLETED
|
6
|
6
|
6
|
5
|
8
|
8
|
12
|
0
|
0
|
0
|
2
|
2
|
2
|
2
|
2
|
2
|
|
HP Period 1
NOT COMPLETED
|
1
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
HP Washout 1
STARTED
|
0
|
0
|
6
|
5
|
8
|
8
|
12
|
0
|
0
|
0
|
2
|
2
|
2
|
2
|
2
|
2
|
|
HP Washout 1
COMPLETED
|
0
|
0
|
5
|
4
|
6
|
6
|
9
|
0
|
0
|
0
|
2
|
2
|
2
|
2
|
2
|
2
|
|
HP Washout 1
NOT COMPLETED
|
0
|
0
|
1
|
1
|
2
|
2
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
HP MAD, Psoriasis MD, HP Fasted/Fed
STARTED
|
0
|
0
|
5
|
4
|
6
|
6
|
9
|
9
|
14
|
7
|
2
|
2
|
2
|
2
|
2
|
2
|
|
HP MAD, Psoriasis MD, HP Fasted/Fed
COMPLETED
|
0
|
0
|
5
|
3
|
6
|
4
|
9
|
7
|
6
|
4
|
2
|
2
|
2
|
2
|
2
|
2
|
|
HP MAD, Psoriasis MD, HP Fasted/Fed
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
2
|
8
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
HP Washout 2
STARTED
|
0
|
0
|
0
|
0
|
6
|
0
|
9
|
0
|
0
|
0
|
2
|
2
|
2
|
2
|
2
|
2
|
|
HP Washout 2
COMPLETED
|
0
|
0
|
0
|
0
|
5
|
0
|
2
|
0
|
0
|
0
|
2
|
2
|
2
|
2
|
2
|
2
|
|
HP Washout 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
HP MAD and Fasted/Fed
STARTED
|
0
|
0
|
0
|
0
|
5
|
0
|
2
|
0
|
0
|
0
|
2
|
2
|
2
|
2
|
2
|
2
|
|
HP MAD and Fasted/Fed
COMPLETED
|
0
|
0
|
0
|
0
|
4
|
0
|
2
|
0
|
0
|
0
|
2
|
2
|
2
|
2
|
2
|
2
|
|
HP MAD and Fasted/Fed
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
PF--06700841: 1 Milligram (mg) SAD Cohort
Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF--06700841: 3 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF--06700841: 10 mg SAD Cohort Then MAD Cohort
Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 10 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
|
PF-06700841: 30 mg SAD Cohort Then MAD Cohort
Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 30 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
|
PF--06700841: 100 mg SAD, 100 mg MAD, 50 mg MAD Cohort
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 100 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days, then PF-06700841 tablet 50 mg orally, twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
|
PF--06700841: 200 mg SAD Cohort, 175 mg MAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 175 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
|
Placebo: SAD Cohort Then MAD Cohort
Healthy participants received placebo matched to PF-06700841 single tablet orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then placebo matched to PF-06700841 tablet once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days followed by placebo matched to PF-06700841 tablet twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tablet Fasted, Tablet Fed, Solution Fasted
Participants received PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 2 (9 days) followed by second washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
|
PF-06700841: 100 mg Solution Fasted, Tablet Fasted, Tablet Fed
Participants received PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
|
PF-06700841: 100 mg Tablet Fed, Solution Fasted, Tablet Fasted
Participants received PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
|
PF-06700841: 100 mg Tablet Fasted, Solution Fasted, Tablet Fed
Participants received PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
|
PF-06700841: 100 mg Solution Fasted, Tablet Fed, Tablet Fasted
Participants received PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
|
PF-06700841: 100 mg Tablet Fed, Tablet Fasted, Solution Fasted
Participants received PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HP Period 1
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
HP Period 1
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
HP Washout 1
Lost to Follow-up
|
0
|
0
|
1
|
1
|
2
|
2
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
HP MAD, Psoriasis MD, HP Fasted/Fed
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
6
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
HP MAD, Psoriasis MD, HP Fasted/Fed
Non-Compliance
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
HP MAD, Psoriasis MD, HP Fasted/Fed
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
HP MAD, Psoriasis MD, HP Fasted/Fed
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
HP Washout 2
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06700841, With Bioavailability/Food Effect Investigation
Baseline characteristics by cohort
| Measure |
PF--06700841: 1 Milligram (mg) SAD Cohort
n=7 Participants
Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF--06700841: 3 mg SAD Cohort
n=6 Participants
Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF--06700841: 10 mg SAD Cohort Then MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 10 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
|
PF-06700841: 30 mg SAD Cohort Then MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 30 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
|
PF--06700841: 100 mg SAD, 100 mg MAD, 50 mg MAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 100 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days, then PF-06700841 tablet 50 mg orally, twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
|
PF--06700841: 200 mg SAD Cohort, 175 mg MAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 175 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
|
Placebo: SAD Cohort Then MAD Cohort
n=13 Participants
Healthy participants received placebo matched to PF-06700841 single tablet orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then placebo matched to PF-06700841 tablet once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days followed by placebo matched to PF-06700841 tablet twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
|
Placebo: MAD Psoriasis Cohort
n=9 Participants
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
n=14 Participants
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
n=7 Participants
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Food Effect Cohort
n=12 Participants
All participants who received either PF-06700841 100 mg tablet under fasted condition or PF-06700841 100 mg tablet under fed condition or PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in any 1 of the 6 treatment sequences in food effects cohort of the study.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18-44 Years
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
1 participants
n=206 Participants
|
4 participants
n=7 Participants
|
5 participants
n=31 Participants
|
6 participants
n=30 Participants
|
11 participants
n=3 Participants
|
6 participants
n=6 Participants
|
6 participants
n=114 Participants
|
5 participants
|
5 participants
n=19 Participants
|
55 participants
n=4 Participants
|
|
Age, Customized
45-64 Years
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
2 participants
n=7 Participants
|
3 participants
n=31 Participants
|
2 participants
n=30 Participants
|
2 participants
n=3 Participants
|
3 participants
n=6 Participants
|
8 participants
n=114 Participants
|
2 participants
|
7 participants
n=19 Participants
|
41 participants
n=4 Participants
|
|
Gender
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
6 Participants
n=4 Participants
|
|
Gender
Male
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
12 Participants
n=114 Participants
|
7 Participants
|
11 Participants
n=19 Participants
|
90 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 hours post-dose on Day 1Population: Full analysis set (FAS) included all participants who were randomized to treatment and received at least 1 dose of study medication.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=7 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=13 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1
Supine Systolic Blood Pressure (SBP): Baseline
|
110.6 millimeter of mercury (mmHg)
Standard Deviation 6.70
|
112.4 millimeter of mercury (mmHg)
Standard Deviation 12.26
|
115.3 millimeter of mercury (mmHg)
Standard Deviation 5.99
|
114.2 millimeter of mercury (mmHg)
Standard Deviation 11.97
|
108.7 millimeter of mercury (mmHg)
Standard Deviation 7.76
|
102.8 millimeter of mercury (mmHg)
Standard Deviation 6.62
|
117.8 millimeter of mercury (mmHg)
Standard Deviation 9.54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1
Supine SBP: Change at Day 1
|
-8.1 millimeter of mercury (mmHg)
Standard Deviation 9.32
|
2.1 millimeter of mercury (mmHg)
Standard Deviation 11.28
|
-5.3 millimeter of mercury (mmHg)
Standard Deviation 7.91
|
-2.6 millimeter of mercury (mmHg)
Standard Deviation 6.40
|
1.0 millimeter of mercury (mmHg)
Standard Deviation 8.17
|
9.5 millimeter of mercury (mmHg)
Standard Deviation 5.96
|
-1.5 millimeter of mercury (mmHg)
Standard Deviation 4.64
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1
Supine Diastolic blood pressure (DBP): Baseline
|
67.0 millimeter of mercury (mmHg)
Standard Deviation 8.77
|
66.9 millimeter of mercury (mmHg)
Standard Deviation 8.98
|
70.5 millimeter of mercury (mmHg)
Standard Deviation 5.88
|
64.0 millimeter of mercury (mmHg)
Standard Deviation 8.55
|
66.2 millimeter of mercury (mmHg)
Standard Deviation 8.42
|
58.7 millimeter of mercury (mmHg)
Standard Deviation 8.19
|
70.3 millimeter of mercury (mmHg)
Standard Deviation 7.39
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1
Supine DBP: Change at Day 1
|
-5.3 millimeter of mercury (mmHg)
Standard Deviation 9.05
|
-0.1 millimeter of mercury (mmHg)
Standard Deviation 8.36
|
-2.3 millimeter of mercury (mmHg)
Standard Deviation 6.14
|
-1.1 millimeter of mercury (mmHg)
Standard Deviation 7.44
|
2.2 millimeter of mercury (mmHg)
Standard Deviation 9.56
|
4.7 millimeter of mercury (mmHg)
Standard Deviation 715
|
2.5 millimeter of mercury (mmHg)
Standard Deviation 8.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 16 hours post-dose on Day 10Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=2 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=5 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=6 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10
Supine SBP: Baseline (n=9,2,5,4,6,5,6)
|
106.5 mmHg
Standard Deviation 3.54
|
108.6 mmHg
Standard Deviation 18.45
|
115.8 mmHg
Standard Deviation 8.66
|
112.2 mmHg
Standard Deviation 9.78
|
103.6 mmHg
Standard Deviation 7.64
|
110.3 mmHg
Standard Deviation 5.19
|
111.5 mmHg
Standard Deviation 13.35
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10
Supine SBP: Change at Day 10 (n=9,2,5,3,6,4,4)
|
12.5 mmHg
Standard Deviation 2.12
|
-3.5 mmHg
Standard Deviation 8.89
|
-5.3 mmHg
Standard Deviation 4.86
|
4.0 mmHg
Standard Deviation 9.12
|
-0.2 mmHg
Standard Deviation 7.69
|
8.7 mmHg
Standard Deviation 10.69
|
7.7 mmHg
Standard Deviation 12.97
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10
Supine DBP: Baseline (n=9,2,5,4,6,5,6)
|
61.5 mmHg
Standard Deviation 7.78
|
59.2 mmHg
Standard Deviation 16.80
|
66.2 mmHg
Standard Deviation 8.06
|
60.3 mmHg
Standard Deviation 4.15
|
56.2 mmHg
Standard Deviation 4.02
|
65.5 mmHg
Standard Deviation 3.70
|
68.8 mmHg
Standard Deviation 9.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10
Supine DBP: Change at Day 10 (n=9,2,5,3,6,4,4)
|
6.0 mmHg
Standard Deviation 4.24
|
-4.3 mmHg
Standard Deviation 9.14
|
2.0 mmHg
Standard Deviation 5.48
|
4.2 mmHg
Standard Deviation 7.26
|
2.2 mmHg
Standard Deviation 6.76
|
5.7 mmHg
Standard Deviation 1.53
|
3.2 mmHg
Standard Deviation 9.62
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 16 hours post-dose on Day 28Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=14 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28
Supine SBP: Baseline (n =9, 14, 7)
|
120.1 mmHg
Standard Deviation 10.91
|
—
|
—
|
115.0 mmHg
Standard Deviation 13.21
|
112.9 mmHg
Standard Deviation 8.11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28
Supine SBP: Change at Day 28 (n =8, 7, 5)
|
-8.9 mmHg
Standard Deviation 9.94
|
—
|
—
|
-5.3 mmHg
Standard Deviation 11.87
|
1.0 mmHg
Standard Deviation 11.94
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28
Supine DBP: Baseline (n =9, 14, 7)
|
69.9 mmHg
Standard Deviation 7.94
|
—
|
—
|
67.8 mmHg
Standard Deviation 7.93
|
66.6 mmHg
Standard Deviation 7.55
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28
Supine DBP: Change at Day 28 (n =8, 7, 5)
|
-7.0 mmHg
Standard Deviation 6.00
|
—
|
—
|
-3.9 mmHg
Standard Deviation 5.51
|
-0.8 mmHg
Standard Deviation 16.96
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 24 hours post-dose on Day 1Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=7 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=13 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1
Baseline
|
68.6 beats per minute (bpm)
Standard Deviation 13.81
|
55.8 beats per minute (bpm)
Standard Deviation 11.77
|
57.8 beats per minute (bpm)
Standard Deviation 6.54
|
57.5 beats per minute (bpm)
Standard Deviation 6.36
|
67.2 beats per minute (bpm)
Standard Deviation 9.66
|
56.0 beats per minute (bpm)
Standard Deviation 8.05
|
67.3 beats per minute (bpm)
Standard Deviation 9.24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1
Change at Day 1
|
6.1 beats per minute (bpm)
Standard Deviation 7.58
|
-1.1 beats per minute (bpm)
Standard Deviation 3.94
|
2.6 beats per minute (bpm)
Standard Deviation 6.39
|
1.0 beats per minute (bpm)
Standard Deviation 3.42
|
2.5 beats per minute (bpm)
Standard Deviation 6.28
|
3.0 beats per minute (bpm)
Standard Deviation 8.10
|
0.7 beats per minute (bpm)
Standard Deviation 5.54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 16 hours post-dose on Day 10Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=2 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=5 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=6 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10
Baseline (n =9,2,5,4,6,5,6)
|
59.0 bpm
Standard Deviation 1.41
|
66.0 bpm
Standard Deviation 9.43
|
60.5 bpm
Standard Deviation 9.61
|
59.3 bpm
Standard Deviation 12.58
|
55.8 bpm
Standard Deviation 7.36
|
60.8 bpm
Standard Deviation 4.99
|
61.5 bpm
Standard Deviation 7.50
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10
Change at Week 10 (n =9,2,5,3,6,4,4,)
|
-0.5 bpm
Standard Deviation 0.71
|
-2.5 bpm
Standard Deviation 4.43
|
-1.0 bpm
Standard Deviation 6.38
|
-2.3 bpm
Standard Deviation 12.21
|
-1.6 bpm
Standard Deviation 5.18
|
-4.0 bpm
Standard Deviation 7.21
|
-6.3 bpm
Standard Deviation 8.24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 16 hours post-dose on Day 28Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=14 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Pulse Rate at Day 28
Baseline (n =9, 14, 7)
|
61.4 bpm
Standard Deviation 9.52
|
—
|
—
|
61.8 bpm
Standard Deviation 8.07
|
64.9 bpm
Standard Deviation 6.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Pulse Rate at Day 28
Change at Week 28 (n =8, 7, 5)
|
-5.3 bpm
Standard Deviation 7.41
|
—
|
—
|
-1.9 bpm
Standard Deviation 5.38
|
-3.0 bpm
Standard Deviation 3.39
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 24 hours post-dose on Day 1Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=7 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=13 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1
Baseline
|
36.83 degree celsius
Standard Deviation 0.359
|
36.69 degree celsius
Standard Deviation 0.164
|
36.63 degree celsius
Standard Deviation 0.149
|
36.79 degree celsius
Standard Deviation 0.155
|
36.65 degree celsius
Standard Deviation 0.187
|
36.82 degree celsius
Standard Deviation 0.194
|
36.80 degree celsius
Standard Deviation 0.141
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1
Change at Day 1
|
-0.11 degree celsius
Standard Deviation 0.418
|
-0.03 degree celsius
Standard Deviation 0.238
|
0.05 degree celsius
Standard Deviation 0.177
|
0.05 degree celsius
Standard Deviation 0.151
|
0.35 degree celsius
Standard Deviation 0.281
|
0.05 degree celsius
Standard Deviation 0.235
|
0.07 degree celsius
Standard Deviation 0.103
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 16 hours post-dose on Day 10Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=2 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=5 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=6 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10
Baseline (n =9, 2, 5, 4, 6, 5, 6)
|
36.70 degree celsius
Standard Deviation 0.141
|
36.76 degree celsius
Standard Deviation 0.167
|
36.75 degree celsius
Standard Deviation 0.235
|
36.71 degree celsius
Standard Deviation 0.136
|
36.76 degree celsius
Standard Deviation 0.182
|
36.68 degree celsius
Standard Deviation 0.126
|
36.83 degree celsius
Standard Deviation 0.163
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10
Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4)
|
0.05 degree celsius
Standard Deviation 0.071
|
-0.17 degree celsius
Standard Deviation 0.206
|
0.05 degree celsius
Standard Deviation 0.208
|
0.08 degree celsius
Standard Deviation 0.228
|
-0.22 degree celsius
Standard Deviation 0.164
|
-0.10 degree celsius
Standard Deviation 0.100
|
-0.22 degree celsius
Standard Deviation 0.214
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 16 hours post-dose on Day 28Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=14 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Oral Temperature at Day 28
Baseline (n = 9, 14, 7)
|
36.67 degrees celsius
Standard Deviation 0.213
|
—
|
—
|
36.74 degrees celsius
Standard Deviation 0.151
|
36.80 degrees celsius
Standard Deviation 0.277
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
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—
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—
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—
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—
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—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Oral Temperature at Day 28
Change at Week 28 (n= 8, 7, 5)
|
-0.04 degrees celsius
Standard Deviation 0.369
|
—
|
—
|
0.01 degrees celsius
Standard Deviation 0.223
|
-0.20 degrees celsius
Standard Deviation 0.300
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
PRIMARY outcome
Timeframe: SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.
Physical examinations included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=7 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=13 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
n=2 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
n=9 Participants
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
n=14 Participants
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
n=7 Participants
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
n=12 Participants
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
n=12 Participants
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
n=12 Participants
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Change From Baseline in Physical Examinations
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline, 24 hours post-dose on Day 1Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=7 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=13 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1
PR Interval: Baseline
|
149.7 millisecond (msec)
Standard Deviation 18.62
|
175.8 millisecond (msec)
Standard Deviation 18.86
|
165.9 millisecond (msec)
Standard Deviation 7.65
|
175.7 millisecond (msec)
Standard Deviation 14.52
|
163.1 millisecond (msec)
Standard Deviation 13.58
|
168.2 millisecond (msec)
Standard Deviation 14.63
|
163.6 millisecond (msec)
Standard Deviation 19.37
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1
PR Interval: Change at Day 1
|
6.7 millisecond (msec)
Standard Deviation 8.12
|
3.3 millisecond (msec)
Standard Deviation 5.62
|
0.5 millisecond (msec)
Standard Deviation 7.54
|
-0.9 millisecond (msec)
Standard Deviation 6.78
|
-2.4 millisecond (msec)
Standard Deviation 6.65
|
2.2 millisecond (msec)
Standard Deviation 5.45
|
-2.1 millisecond (msec)
Standard Deviation 5.95
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1
QRS Complex: Baseline
|
92.9 millisecond (msec)
Standard Deviation 9.30
|
101.7 millisecond (msec)
Standard Deviation 6.87
|
92.0 millisecond (msec)
Standard Deviation 5.81
|
97.7 millisecond (msec)
Standard Deviation 15.40
|
97.4 millisecond (msec)
Standard Deviation 10.43
|
102.9 millisecond (msec)
Standard Deviation 8.74
|
99.8 millisecond (msec)
Standard Deviation 14.61
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1
QRS Complex: Change at Day 1
|
-1.5 millisecond (msec)
Standard Deviation 5.98
|
-2.0 millisecond (msec)
Standard Deviation 5.19
|
1.7 millisecond (msec)
Standard Deviation 2.33
|
-3.1 millisecond (msec)
Standard Deviation 12.73
|
-2.2 millisecond (msec)
Standard Deviation 4.06
|
-1.7 millisecond (msec)
Standard Deviation 3.55
|
-2.9 millisecond (msec)
Standard Deviation 3.45
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1
QT Interval: Baseline
|
374.0 millisecond (msec)
Standard Deviation 21.81
|
421.3 millisecond (msec)
Standard Deviation 29.94
|
407.1 millisecond (msec)
Standard Deviation 20.71
|
408.4 millisecond (msec)
Standard Deviation 21.42
|
384.3 millisecond (msec)
Standard Deviation 26.20
|
404.2 millisecond (msec)
Standard Deviation 19.89
|
387.5 millisecond (msec)
Standard Deviation 12.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1
QT Interval: Change at Day 1
|
-3.8 millisecond (msec)
Standard Deviation 10.21
|
-0.8 millisecond (msec)
Standard Deviation 11.61
|
-3.3 millisecond (msec)
Standard Deviation 14.78
|
-5.9 millisecond (msec)
Standard Deviation 10.41
|
-3.1 millisecond (msec)
Standard Deviation 9.43
|
-8.2 millisecond (msec)
Standard Deviation 9.25
|
-0.8 millisecond (msec)
Standard Deviation 4.56
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1
QTC Interval: Baseline
|
390.9 millisecond (msec)
Standard Deviation 20.95
|
400.0 millisecond (msec)
Standard Deviation 7.60
|
402.7 millisecond (msec)
Standard Deviation 14.10
|
397.7 millisecond (msec)
Standard Deviation 16.51
|
400.6 millisecond (msec)
Standard Deviation 11.90
|
392.2 millisecond (msec)
Standard Deviation 13.42
|
402.7 millisecond (msec)
Standard Deviation 20.69
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1
QTC Interval: Change at Day 1
|
-2.3 millisecond (msec)
Standard Deviation 5.45
|
4.2 millisecond (msec)
Standard Deviation 7.75
|
3.2 millisecond (msec)
Standard Deviation 5.76
|
-0.2 millisecond (msec)
Standard Deviation 9.24
|
-1.9 millisecond (msec)
Standard Deviation 7.61
|
2.4 millisecond (msec)
Standard Deviation 9.42
|
-4.6 millisecond (msec)
Standard Deviation 4.41
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 16 hours post-dose on Day 10Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=2 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=5 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=6 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10
PR Interval: Baseline (n =9,2,5,4,6,5,6)
|
180.0 msec
Standard Deviation 1.41
|
171.6 msec
Standard Deviation 14.77
|
168.0 msec
Standard Deviation 6.66
|
176.9 msec
Standard Deviation 16.31
|
167.6 msec
Standard Deviation 10.69
|
169.0 msec
Standard Deviation 22.38
|
168.5 msec
Standard Deviation 18.79
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10
PR Interval: Change at Day 10 (n =9,2,5,3,6,4,4)
|
4.7 msec
Standard Deviation 6.60
|
11.2 msec
Standard Deviation 5.14
|
1.4 msec
Standard Deviation 2.33
|
5.2 msec
Standard Deviation 3.59
|
7.7 msec
Standard Deviation 5.36
|
14.3 msec
Standard Deviation 8.41
|
7.3 msec
Standard Deviation 10.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10
QRS Complex: Baseline (n =9,2,5,4,6,5,6)
|
96.0 msec
Standard Deviation 7.07
|
103.0 msec
Standard Deviation 8.34
|
95.2 msec
Standard Deviation 8.70
|
96.6 msec
Standard Deviation 5.83
|
103.0 msec
Standard Deviation 9.14
|
101.0 msec
Standard Deviation 20.05
|
102.7 msec
Standard Deviation 8.52
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10
QRS Complex: Change at Day 10 (n =9,2,5,3,6,4,4)
|
-0.5 msec
Standard Deviation 6.36
|
2.9 msec
Standard Deviation 5.26
|
-1.7 msec
Standard Deviation 1.83
|
0.9 msec
Standard Deviation 1.60
|
-3.2 msec
Standard Deviation 9.49
|
-2.3 msec
Standard Deviation 6.17
|
1.3 msec
Standard Deviation 5.32
|
—
|
—
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—
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—
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—
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—
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—
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—
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Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10
QT Interval: Baseline (n =9,2,5,4,6,5,6)
|
425.5 msec
Standard Deviation 10.61
|
397.0 msec
Standard Deviation 23.29
|
401.8 msec
Standard Deviation 27.66
|
411.9 msec
Standard Deviation 27.98
|
407.4 msec
Standard Deviation 18.17
|
398.0 msec
Standard Deviation 9.56
|
399.7 msec
Standard Deviation 16.12
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10
QT Interval: Change at Day 10 (n =9,2,5,3,6,4,4)
|
1.0 msec
Standard Deviation 11.79
|
2.3 msec
Standard Deviation 5.51
|
2.1 msec
Standard Deviation 23.19
|
-3.9 msec
Standard Deviation 14.72
|
-1.0 msec
Standard Deviation 23.42
|
2.6 msec
Standard Deviation 9.26
|
1.3 msec
Standard Deviation 16.66
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10
QTC Interval: Baseline (n =9,2,5,4,6,5,6)
|
415.5 msec
Standard Deviation 4.95
|
403.2 msec
Standard Deviation 6.26
|
403.5 msec
Standard Deviation 11.96
|
398.7 msec
Standard Deviation 11.35
|
396.4 msec
Standard Deviation 15.53
|
401.5 msec
Standard Deviation 15.37
|
396.0 msec
Standard Deviation 6.54
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10
QTC Interval: Change at Day 10 (n =9,2,5,3,6,4,4)
|
-1.5 msec
Standard Deviation 10.14
|
-0.3 msec
Standard Deviation 4.46
|
2.0 msec
Standard Deviation 10.47
|
-0.3 msec
Standard Deviation 9.82
|
-2.9 msec
Standard Deviation 3.00
|
-5.0 msec
Standard Deviation 10.49
|
-1.3 msec
Standard Deviation 10.34
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: Baseline, 16 hours post-dose on Day 28Population: FAS included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=14 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28
PR Interval: Baseline (n =9, 14, 7)
|
156.1 msec
Standard Deviation 17.78
|
—
|
—
|
169.4 msec
Standard Deviation 15.26
|
154.7 msec
Standard Deviation 11.51
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28
PR Interval: Change at Day 28 (n =8, 7, 5)
|
11.1 msec
Standard Deviation 5.95
|
—
|
—
|
-0.6 msec
Standard Deviation 10.19
|
4.1 msec
Standard Deviation 7.09
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28
QRS Complex: Baseline (n =9, 14, 7)
|
97.4 msec
Standard Deviation 10.27
|
—
|
—
|
100.6 msec
Standard Deviation 8.32
|
93.0 msec
Standard Deviation 5.87
|
—
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—
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—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28
QRS Complex: Change at Day 28 (n= 8, 7, 5)
|
0.8 msec
Standard Deviation 4.73
|
—
|
—
|
0.5 msec
Standard Deviation 4.86
|
3.8 msec
Standard Deviation 5.26
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
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—
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—
|
—
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—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28
QT Interval: Baseline (n =9, 14, 7)
|
411.6 msec
Standard Deviation 31.01
|
—
|
—
|
404.4 msec
Standard Deviation 17.48
|
379.0 msec
Standard Deviation 18.94
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28
QT Interval: Change at Day 28 (n =8, 7, 5)
|
-22.6 msec
Standard Deviation 23.04
|
—
|
—
|
-17.9 msec
Standard Deviation 16.00
|
-5.3 msec
Standard Deviation 9.43
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28
QTC Interval: Baseline (n=9, 14, 7)
|
409.0 msec
Standard Deviation 14.92
|
—
|
—
|
409.7 msec
Standard Deviation 14.46
|
392.0 msec
Standard Deviation 19.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28
QTC Interval: Change at Day 28 (n= 8, 7, 5)
|
-9.6 msec
Standard Deviation 7.89
|
—
|
—
|
-8.7 msec
Standard Deviation 10.83
|
-2.7 msec
Standard Deviation 13.18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 24 hours post-dose on Day 1Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=7 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=13 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1
Baseline
|
70.3 bpm
Standard Deviation 16.46
|
53.0 bpm
Standard Deviation 8.92
|
58.0 bpm
Standard Deviation 5.17
|
56.1 bpm
Standard Deviation 6.83
|
69.2 bpm
Standard Deviation 12.06
|
55.3 bpm
Standard Deviation 5.65
|
67.7 bpm
Standard Deviation 8.82
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1
Change at Day 1
|
1.6 bpm
Standard Deviation 2.81
|
2.0 bpm
Standard Deviation 3.19
|
3.4 bpm
Standard Deviation 5.79
|
2.2 bpm
Standard Deviation 3.74
|
0.3 bpm
Standard Deviation 3.27
|
4.6 bpm
Standard Deviation 4.64
|
-2.3 bpm
Standard Deviation 1.72
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 16 hours post-dose on Day 10Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=2 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=5 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=6 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10
Baseline (n =9, 2, 5, 4, 6, 5, 6)
|
55.5 bpm
Standard Deviation 2.12
|
63.0 bpm
Standard Deviation 7.38
|
61.2 bpm
Standard Deviation 7.96
|
55.1 bpm
Standard Deviation 7.15
|
55.4 bpm
Standard Deviation 4.45
|
61.0 bpm
Standard Deviation 2.94
|
58.5 bpm
Standard Deviation 6.38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10
Change at Day 10 (n = 9, 2, 5, 3, 6, 4, 4)
|
7.7 bpm
Standard Deviation 6.13
|
-1.8 bpm
Standard Deviation 5.79
|
-1.3 bpm
Standard Deviation 4.04
|
-1.2 bpm
Standard Deviation 10.33
|
-1.1 bpm
Standard Deviation 7.22
|
-3.0 bpm
Standard Deviation 4.04
|
-2.3 bpm
Standard Deviation 5.12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 16 hours post-dose on Day 28Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=14 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Heart Rate at Day 28
Baseline (n =9, 14, 7)
|
60.2 bpm
Standard Deviation 11.25
|
—
|
—
|
63.1 bpm
Standard Deviation 9.15
|
66.0 bpm
Standard Deviation 4.93
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Heart Rate at Day 28
Change at Day 28 (n =8, 7, 5)
|
4.0 bpm
Standard Deviation 8.73
|
—
|
—
|
5.2 bpm
Standard Deviation 5.28
|
1.4 bpm
Standard Deviation 5.60
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug up to the end of study (up to Day 8 in SAD cohort, Day 28 in MAD cohort, Day 56 in MAD Psoriasis cohort, Day 37 in Food effect cohort), that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=7 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=13 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
n=2 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
n=9 Participants
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
n=14 Participants
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
n=7 Participants
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
n=12 Participants
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
n=12 Participants
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
n=12 Participants
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs
AEs
|
1 participants
|
3 participants
|
2 participants
|
2 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
3 participants
|
2 participants
|
3 participants
|
5 participants
|
5 participants
|
5 participants
|
11 participants
|
6 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs
SAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs
Withdrawal due to AEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
6 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=7 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=13 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
n=2 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
n=9 Participants
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
n=14 Participants
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
n=7 Participants
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
n=12 Participants
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
n=12 Participants
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
n=12 Participants
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Adverse Events (AEs) According to Severity
Mild
|
1 adverse events
|
4 adverse events
|
0 adverse events
|
2 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
3 adverse events
|
2 adverse events
|
2 adverse events
|
6 adverse events
|
6 adverse events
|
7 adverse events
|
16 adverse events
|
16 adverse events
|
1 adverse events
|
2 adverse events
|
0 adverse events
|
|
Number of Adverse Events (AEs) According to Severity
Moderate
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events (AEs) According to Severity
Severe
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
PRIMARY outcome
Timeframe: SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.
Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count: less than(\<) 0.8\*lower limit of normal (LLN); mean corpuscular volume; mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration: \<0.9\*LLN,\>1.1\*upper limit of normal (ULN); platelets: \<0.5\*LLN,\>1.75\*ULN, white blood cell count: \<0.6\*LLN, \>1.5\*ULN; lymphocytes, total neutrophils: \<0.8\*LLN, \>1.2\*ULN; eosinophils, basophils, monocytes: \>1.2\*ULN; coagulation: activated partial thromboplastin time, prothrombin, prothrombin international ratio: \>1.1\*ULN; liver function: bilirubin: \>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \>3.0\*ULN; protein, albumin: \<0.8\*LLN\>\</0\>1.2\*ULN; renal function:blood urea nitrogen,creatinine: \>1.3\*ULN; uric acid: \>1.2\*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: \<0.9\*LLN,\>1.1\*ULN; urinalysis: pH\<4.5, \>8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: \<0.6\*LLN,\>1.5\*ULN)
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=7 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=13 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
n=2 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
n=9 Participants
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
n=14 Participants
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
n=7 Participants
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
n=12 Participants
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
n=12 Participants
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
n=12 Participants
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities
|
4 participants
|
6 participants
|
7 participants
|
7 participants
|
4 participants
|
6 participants
|
6 participants
|
6 participants
|
0 participants
|
5 participants
|
4 participants
|
6 participants
|
5 participants
|
6 participants
|
7 participants
|
13 participants
|
7 participants
|
5 participants
|
1 participants
|
3 participants
|
PRIMARY outcome
Timeframe: Baseline, 24 hours post-dose on Day 1Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Creatinine clearance is a measure of kidney function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=7 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=12 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1
Baseline
|
93.0 milliliter per minute (mL/min)
Standard Deviation 36.60
|
129.6 milliliter per minute (mL/min)
Standard Deviation 25.43
|
114.4 milliliter per minute (mL/min)
Standard Deviation 24.64
|
117.7 milliliter per minute (mL/min)
Standard Deviation 28.70
|
133.8 milliliter per minute (mL/min)
Standard Deviation 29.76
|
95.8 milliliter per minute (mL/min)
Standard Deviation 53.07
|
117.0 milliliter per minute (mL/min)
Standard Deviation 28.70
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1
Change at Day 1
|
-0.4 milliliter per minute (mL/min)
Standard Deviation 35.35
|
-17.6 milliliter per minute (mL/min)
Standard Deviation 28.67
|
73.4 milliliter per minute (mL/min)
Standard Deviation 227.50
|
24.3 milliliter per minute (mL/min)
Standard Deviation 63.75
|
-2.7 milliliter per minute (mL/min)
Standard Deviation 11.27
|
15.8 milliliter per minute (mL/min)
Standard Deviation 36.79
|
-6.4 milliliter per minute (mL/min)
Standard Deviation 6.35
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 16 hours post-dose on Day 10Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Creatinine clearance is a measure of kidney function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=2 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=5 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=6 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
n=14 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10
Baseline (n =9, 2, 5, 4, 6, 5, 6, 2, 2, 7)
|
111.0 mL/min
Standard Deviation 1.41
|
138.4 mL/min
Standard Deviation 51.27
|
83.0 mL/min
Standard Deviation 39.73
|
114.4 mL/min
Standard Deviation 27.75
|
112.6 mL/min
Standard Deviation 42.08
|
115.0 mL/min
Standard Deviation 34.13
|
142.5 mL/min
Standard Deviation 56.68
|
140.5 mL/min
Standard Deviation 55.86
|
158.0 mL/min
Standard Deviation 36.77
|
172.4 mL/min
Standard Deviation 51.74
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10
Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4, 2, 2, 7)
|
-2.5 mL/min
Standard Deviation 57.28
|
-39.5 mL/min
Standard Deviation 29.86
|
3.5 mL/min
Standard Deviation 40.42
|
0.7 mL/min
Standard Deviation 33.29
|
26.8 mL/min
Standard Deviation 46.90
|
-19.0 mL/min
Standard Deviation 25.51
|
-47.0 mL/min
Standard Deviation 55.68
|
-38.5 mL/min
Standard Deviation 60.10
|
-50.0 mL/min
Standard Deviation 4.24
|
-67.3 mL/min
Standard Deviation 61.45
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 16 hours post-dose on Day 28Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'N' signifies those participants who were evaluable for this outcome measure.
Creatinine clearance is a measure of kidney function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=2 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=1 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 28
|
-35.0 mL/min
Standard Deviation 33.94
|
—
|
—
|
-10.0 mL/min
Standard Deviation 0.0
|
-67.6 mL/min
Standard Deviation 50.33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=12 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=12 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=12 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Food Effect Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841
|
6720 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 43
|
—
|
—
|
6463 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 46
|
5321 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 53
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast).
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=12 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=12 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=12 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Food Effect Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841
|
6694 ng*hr/mL
Geometric Coefficient of Variation 43
|
—
|
—
|
6447 ng*hr/mL
Geometric Coefficient of Variation 46
|
5305 ng*hr/mL
Geometric Coefficient of Variation 53
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=12 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=12 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=12 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Food Effect Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841
|
1084 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 40
|
—
|
—
|
1022 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
656.6 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 26
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: pre-dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post dose on Day 1; MAD: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=6 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=5 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=7 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=8 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
n=3 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
n=6 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841
|
18.21 ng/mL
Geometric Coefficient of Variation 92
|
2460 ng/mL
Geometric Coefficient of Variation 37
|
63.42 ng/mL
Geometric Coefficient of Variation 11
|
5.138 ng/mL
Geometric Coefficient of Variation 52
|
79.30 ng/mL
Geometric Coefficient of Variation 35
|
271.3 ng/mL
Geometric Coefficient of Variation 21
|
748.4 ng/mL
Geometric Coefficient of Variation 35
|
286.6 ng/mL
Geometric Coefficient of Variation 17
|
734.1 ng/mL
Geometric Coefficient of Variation 29
|
522.0 ng/mL
Geometric Coefficient of Variation 31
|
2091 ng/mL
Geometric Coefficient of Variation 28
|
204.7 ng/mL
Geometric Coefficient of Variation 43
|
924.2 ng/mL
Geometric Coefficient of Variation 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: pre-dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post dose on Day 1; MAD: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=6 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=5 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=7 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=8 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
n=3 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
n=6 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841
|
1.00 hour
Interval 0.5 to 1.0
|
1.00 hour
Interval 0.5 to 2.0
|
1.00 hour
Interval 1.0 to 1.03
|
1.00 hour
Interval 0.5 to 2.0
|
0.500 hour
Interval 0.5 to 1.0
|
1.00 hour
Interval 0.5 to 1.02
|
1.00 hour
Interval 0.5 to 2.0
|
1.00 hour
Interval 1.0 to 1.0
|
1.50 hour
Interval 1.0 to 2.0
|
1.00 hour
Interval 1.0 to 2.0
|
0.984 hour
Interval 0.5 to 2.0
|
1.00 hour
Interval 0.983 to 1.0
|
2.00 hour
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre--dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=12 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=12 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=12 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Food Effect Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF--06700841
|
1.00 hour
Full Range 1.2965 • Interval 0.5 to 2.0
|
—
|
—
|
0.500 hour
Full Range 0.500 • Interval 0.5 to 2.0
|
4.00 hour
Full Range 1.4383 • Interval 1.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort arm
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=5 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=2 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (SAD) Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841
|
145.8 ng*hr/mL
Geometric Coefficient of Variation 61 • Interval 0.5 to 1.0
|
18410 ng*hr/mL
Geometric Coefficient of Variation 46 • Interval 0.5 to 2.0
|
—
|
NA ng*hr/mL
Geometric Coefficient of Variation NA • Interval 0.5 to 2.0
Data was not collected due to less than 3 participants were evaluable and considered insufficient to calculate a reliable estimation, by investigator.
|
353.8 ng*hr/mL
Geometric Coefficient of Variation 31 • Interval 0.5 to 1.0
|
1439 ng*hr/mL
Geometric Coefficient of Variation 65 • Interval 0.5 to 1.02
|
4797 ng*hr/mL
Geometric Coefficient of Variation 62 • Interval 0.5 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: MAD: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: MAD Cohort, MAD Psoriasis Cohort arm
Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort and 24 hours for MAD Psoriasis cohort.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=3 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=7 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=5 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=5 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06700841
|
1880 ng*hr/mL
Geometric Coefficient of Variation 52
|
990.0 ng*hr/mL
Geometric Coefficient of Variation 103
|
7672 ng*hr/mL
Geometric Coefficient of Variation 43
|
422.8 ng*hr/mL
Geometric Coefficient of Variation 41
|
6089 ng*hr/mL
Geometric Coefficient of Variation 38
|
3560 ng*hr/mL
Geometric Coefficient of Variation 35
|
16180 ng*hr/mL
Geometric Coefficient of Variation 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort arm
Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast).
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=6 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=6 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=8 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (SAD) Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841
|
79.18 ng*hr/mL
Geometric Coefficient of Variation 239 • Interval 0.5 to 1.0
|
18400 ng*hr/mL
Geometric Coefficient of Variation 46 • Interval 0.5 to 2.0
|
—
|
17.71 ng*hr/mL
Geometric Coefficient of Variation 114 • Interval 0.5 to 2.0
|
340.4 ng*hr/mL
Geometric Coefficient of Variation 30 • Interval 0.5 to 1.0
|
1431 ng*hr/mL
Geometric Coefficient of Variation 65 • Interval 0.5 to 1.02
|
5041 ng*hr/mL
Geometric Coefficient of Variation 59 • Interval 0.5 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: pre-dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post dose on Day 1; MAD: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.
Dose normalized (dn) Cmax was calculated by dividing Cmax by the exact dose of PF 06700841 (in mg) administered to a participant.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=6 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=5 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=7 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=8 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
n=3 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
n=6 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06700841
|
6.061 [nanogram/milliliter]/milligram
Geometric Coefficient of Variation 92
|
12.31 [nanogram/milliliter]/milligram
Geometric Coefficient of Variation 37
|
6.342 [nanogram/milliliter]/milligram
Geometric Coefficient of Variation 11
|
5.138 [nanogram/milliliter]/milligram
Geometric Coefficient of Variation 52
|
7.930 [nanogram/milliliter]/milligram
Geometric Coefficient of Variation 35
|
9.033 [nanogram/milliliter]/milligram
Geometric Coefficient of Variation 21
|
7.484 [nanogram/milliliter]/milligram
Geometric Coefficient of Variation 35
|
9.563 [nanogram/milliliter]/milligram
Geometric Coefficient of Variation 17
|
7.341 [nanogram/milliliter]/milligram
Geometric Coefficient of Variation 29
|
10.43 [nanogram/milliliter]/milligram
Geometric Coefficient of Variation 30
|
11.97 [nanogram/milliliter]/milligram
Geometric Coefficient of Variation 28
|
6.827 [nanogram/milliliter]/milligram
Geometric Coefficient of Variation 43
|
9.242 [nanogram/milliliter]/milligram
Geometric Coefficient of Variation 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort arm.
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUCinf(dn) was calculated by dividing AUCinf by the exact dose of PF-06700841 (in mg) administered to a participant.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=5 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=2 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf[dn]) of PF-06700841
|
48.65 [nanogram*hour/milliliter]/milligram
Geometric Coefficient of Variation 61 • Interval 0.5 to 1.0
|
92.13 [nanogram*hour/milliliter]/milligram
Geometric Coefficient of Variation 46 • Interval 0.5 to 2.0
|
—
|
NA [nanogram*hour/milliliter]/milligram
Geometric Coefficient of Variation NA • Interval 0.5 to 2.0
Data was not collected due to less than 3 participants were evaluable and considered insufficient to calculate a reliable estimation, by investigator.
|
35.38 [nanogram*hour/milliliter]/milligram
Geometric Coefficient of Variation 31 • Interval 0.5 to 1.0
|
47.97 [nanogram*hour/milliliter]/milligram
Geometric Coefficient of Variation 65 • Interval 0.5 to 1.02
|
47.97 [nanogram*hour/milliliter]/milligram
Geometric Coefficient of Variation 62 • Interval 0.5 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort arm.
Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast). AUClast(dn) was calculated by dividing AUClast by the exact dose of of PF-06700841 (in mg) administered to a participant.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=6 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=6 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=8 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of PF-06700841
|
26.38 [ng*hr/mL]/mg
Geometric Coefficient of Variation 239 • Interval 0.5 to 1.0
|
92.09 [ng*hr/mL]/mg
Geometric Coefficient of Variation 46 • Interval 0.5 to 2.0
|
—
|
17.71 [ng*hr/mL]/mg
Geometric Coefficient of Variation 114 • Interval 0.5 to 2.0
|
34.04 [ng*hr/mL]/mg
Geometric Coefficient of Variation 30 • Interval 0.5 to 1.0
|
47.64 [ng*hr/mL]/mg
Geometric Coefficient of Variation 65 • Interval 0.5 to 1.02
|
50.41 [ng*hr/mL]/mg
Geometric Coefficient of Variation 59 • Interval 0.5 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo Once Daily and Twice Daily: MAD Cohort arms.
Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort. AUCtau(dn) was calculated by dividing AUCtau by the exact dose of of PF-06700841 (in mg) administered to a participant.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=3 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=5 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau[dn]) of PF-06700841
|
62.68 [ng*hr/mL]/mg
Geometric Coefficient of Variation 51
|
—
|
—
|
42.28 [ng*hr/mL]/mg
Geometric Coefficient of Variation 41
|
60.89 [ng*hr/mL]/mg
Geometric Coefficient of Variation 38
|
71.15 [ng*hr/mL]/mg
Geometric Coefficient of Variation 36
|
92.30 [ng*hr/mL]/mg
Geometric Coefficient of Variation 16
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: pre--dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post-dose on Day 1; MAD: pre--dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre--dose, 0.5,1,2,4,6,8,12,16,24 hours post-dose on Day 28Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.
Plasma decay half-life is the time measured for the plasma concentration of PF-06700841 to decrease by one half.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=5 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=5 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=2 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
n=3 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
n=6 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
n=12 Participants
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
n=12 Participants
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
n=12 Participants
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841
|
4.554 hour
Standard Deviation 1.8066 • Interval 0.5 to 1.0
|
6.813 hour
Standard Deviation 1.9875 • Interval 0.5 to 2.0
|
5.928 hour
Standard Deviation 3.3336 • Interval 1.0 to 1.03
|
NA hour
Standard Deviation NA • Interval 0.5 to 2.0
Data was not collected due to less than 3 participants were evaluable and considered insufficient to calculate a reliable estimation, by investigator.
|
3.848 hour
Standard Deviation 1.1587 • Interval 0.5 to 1.0
|
4.363 hour
Standard Deviation 2.4126 • Interval 0.5 to 1.02
|
7.519 hour
Standard Deviation 2.8236 • Interval 0.5 to 2.0
|
4.860 hour
Standard Deviation 1.9304 • Interval 1.0 to 1.0
|
10.67 hour
Standard Deviation 1.8440 • Interval 1.0 to 2.0
|
9.133 hour
Standard Deviation 2.2579 • Interval 1.0 to 2.0
|
7.458 hour
Standard Deviation 2.1595 • Interval 0.5 to 2.0
|
16.01 hour
Standard Deviation 31.584 • Interval 0.983 to 2.0
|
6.032 hour
Standard Deviation 1.7121 • Interval 1.0 to 2.0
|
6.155 hour
Standard Deviation 1.4408 • Interval 0.5 to 2.0
|
6.168 hour
Standard Deviation 1.2965 • Interval 0.5 to 2.0
|
5.848 hour
Standard Deviation 1.4383 • Interval 1.0 to 4.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: pre--dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post-dose on Day 1; MAD: pre--dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post--dose on Day 10; MAD Psoriasis: pre--dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose on Day 28Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.
MRT= AUMCinf/AUCinf, where AUMCinf is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=5 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=5 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=2 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
n=3 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
n=6 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Mean Residence Time (MRT) of PF-06700841
|
6.414 hour
Geometric Coefficient of Variation 46
|
8.758 hour
Geometric Coefficient of Variation 29
|
7.191 hour
Geometric Coefficient of Variation 45
|
NA hour
Geometric Coefficient of Variation NA
Data was not collected due to less than 3 participants were evaluable and considered insufficient to calculate a reliable estimation, by investigator.
|
5.169 hour
Geometric Coefficient of Variation 34
|
5.206 hour
Geometric Coefficient of Variation 44
|
7.277 hour
Geometric Coefficient of Variation 37
|
6.830 hour
Geometric Coefficient of Variation 38
|
10.35 hour
Geometric Coefficient of Variation 25
|
9.592 hour
Geometric Coefficient of Variation 22
|
9.025 hour
Geometric Coefficient of Variation 26
|
6.072 hour
Geometric Coefficient of Variation 92
|
8.534 hour
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post-dose on Day 1; MAD: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose on Day 28Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=5 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=5 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=2 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
n=3 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
n=6 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Volume of Distribution (Vz/F) of PF-06700841
|
126.4 liter
Standard Deviation 26 • Interval 0.5 to 1.0
|
102.4 liter
Standard Deviation 27 • Interval 0.5 to 2.0
|
177.6 liter
Standard Deviation 30 • Interval 1.0 to 1.03
|
NA liter
Standard Deviation NA • Interval 0.5 to 2.0
Data was not collected due to less than 3 participants were evaluable and considered insufficient to calculate a reliable estimation, by investigator.
|
151.0 liter
Standard Deviation 18 • Interval 0.5 to 1.0
|
115.7 liter
Standard Deviation 16 • Interval 0.5 to 1.02
|
210.5 liter
Standard Deviation 45 • Interval 0.5 to 2.0
|
106.2 liter
Standard Deviation 12 • Interval 1.0 to 1.0
|
249.4 liter
Standard Deviation 45 • Interval 1.0 to 2.0
|
180.9 liter
Standard Deviation 30 • Interval 1.0 to 2.0
|
112.4 liter
Standard Deviation 18 • Interval 0.5 to 2.0
|
245.4 liter
Standard Deviation 206 • Interval 0.983 to 2.0
|
109.6 liter
Standard Deviation 18 • Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post-dose on Day 1; MAD: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose on Day 28Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Clearance obtained after oral dose is influenced by the fraction of the dose absorbed. CL/F =Dose of PF-06700841/AUCinf.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=5 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=5 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=2 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
n=3 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
n=6 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Clearance (CL/F) of PF-06700841
|
20.57 Liter per hour (L/hr)
Geometric Coefficient of Variation 61
|
10.86 Liter per hour (L/hr)
Geometric Coefficient of Variation 46
|
23.65 Liter per hour (L/hr)
Geometric Coefficient of Variation 41
|
NA Liter per hour (L/hr)
Geometric Coefficient of Variation NA
Data was not collected due to less than 3 participants were evaluable and considered insufficient to calculate a reliable estimation, by investigator.
|
28.26 Liter per hour (L/hr)
Geometric Coefficient of Variation 31
|
20.82 Liter per hour (L/hr)
Geometric Coefficient of Variation 65
|
20.85 Liter per hour (L/hr)
Geometric Coefficient of Variation 61
|
15.95 Liter per hour (L/hr)
Geometric Coefficient of Variation 51
|
16.43 Liter per hour (L/hr)
Geometric Coefficient of Variation 38
|
14.03 Liter per hour (L/hr)
Geometric Coefficient of Variation 35
|
10.83 Liter per hour (L/hr)
Geometric Coefficient of Variation 16
|
30.30 Liter per hour (L/hr)
Geometric Coefficient of Variation 103
|
13.04 Liter per hour (L/hr)
Geometric Coefficient of Variation 43
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: MAD: pre--dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post--dose on Day 10; MAD Psoriasis: pre--dose, 0.5,1,2,4,6,8,12,16,24 hours post-dose on Day 28Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: MAD Cohort, MAD Psoriasis Cohort arm.
PTF was calculated as: Cmax-Cmin/Cavg. Cmax is the maximum observed plasma concentration of PF-06700841. Cmin is the minimum observed plasma concentration of PF-06700841. Cavg is the average observed plasma concentration of PF-06700841 calculated as area under the plasma concentration-time curve during a dosing Interval (AUC\[tau\]) divided by the dosing interval (tau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort and 24 hours for MAD Psoriasis cohort.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=3 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=4 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=5 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=3 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Peak-Trough Fluctuation (PTF) of PF-06700841
|
3.543 ratio
Geometric Coefficient of Variation 38
|
3.414 ratio
Geometric Coefficient of Variation 44
|
2.654 ratio
Geometric Coefficient of Variation 42
|
2.815 ratio
Geometric Coefficient of Variation 40
|
2.643 ratio
Geometric Coefficient of Variation 31
|
1.297 ratio
Geometric Coefficient of Variation 22
|
2.911 ratio
Geometric Coefficient of Variation 43
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-24 hour on Day 10Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo Once Daily and Twice Daily: MAD Cohort arms.
Aetau is the amount of drug recovered unchanged in urine during the dosing interval (tau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=3 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=5 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=1 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Cohort: Amount of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau)
|
2.798 milligram
Geometric Coefficient of Variation 57
|
—
|
—
|
1.109 milligram
Geometric Coefficient of Variation 45
|
NA milligram
Geometric Coefficient of Variation NA
Data was not collected due to less than 3 participants were evaluable and considered insufficient to calculate a reliable estimation, by investigator.
|
7.758 milligram
Geometric Coefficient of Variation 57
|
15.60 milligram
Geometric Coefficient of Variation 44
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-24 hours on Day 10Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo Once Daily and Twice Daily: MAD Cohort arms.
Aetau% was calculated as: 100\*Aetau/dose. Aetau is the amount of drug recovered unchanged in urine during the dosing interval (tau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=3 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=5 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Cohort: Percentage of Dose of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau%)
|
9.332 percentage of dose recovered
Geometric Coefficient of Variation 57
|
—
|
—
|
11.09 percentage of dose recovered
Geometric Coefficient of Variation 45
|
NA percentage of dose recovered
Geometric Coefficient of Variation NA
Data was not collected due to less than 3 participants were evaluable and considered insufficient to calculate a reliable estimation, by investigator.
|
15.54 percentage of dose recovered
Geometric Coefficient of Variation 57
|
8.910 percentage of dose recovered
Geometric Coefficient of Variation 44
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-24 hours on Day 10Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo Once Daily and Twice Daily: MAD Cohort arms.
Renal clearance was calculated as amount of drug recovered unchanged in urine during the dosing interval tau (Aetau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=3 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=5 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=1 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Cohort: Renal Clearance
|
1.486 Liter per hour
Geometric Coefficient of Variation 15
|
—
|
—
|
2.619 Liter per hour
Geometric Coefficient of Variation 18
|
NA Liter per hour
Geometric Coefficient of Variation NA
Data was not collected due to less than 3 participants were evaluable and considered insufficient to calculate a reliable estimation, by investigator.
|
2.179 Liter per hour
Geometric Coefficient of Variation 31
|
0.9629 Liter per hour
Geometric Coefficient of Variation 58
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Pharmacodynamic (PD) analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest.
Serum samples for IP-10 were analyzed using a validated analytical assay. Lower limit of quantification (LLOQ) for IP-10 was 10 pg/mL.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=7 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=13 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (SAD) Cohort: Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Baseline
|
188.76 picogram per milliliter (pg/mL)
Standard Deviation 238.380
|
115.00 picogram per milliliter (pg/mL)
Standard Deviation 38.458
|
114.33 picogram per milliliter (pg/mL)
Standard Deviation 26.164
|
119.17 picogram per milliliter (pg/mL)
Standard Deviation 40.090
|
219.62 picogram per milliliter (pg/mL)
Standard Deviation 275.440
|
78.28 picogram per milliliter (pg/mL)
Standard Deviation 29.481
|
141.38 picogram per milliliter (pg/mL)
Standard Deviation 100.403
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 2, 5, 10, 11, 28Population: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
Serum samples for IP-10 were analyzed using a validated analytical assay. LLOQ for IP-10 was 10 pg/mL.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=2 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=5 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=6 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28
Baseline (n =9, 2, 5, 4, 6, 5, 6)
|
85.50 pg/mL
Standard Deviation 13.011
|
121.60 pg/mL
Standard Deviation 20.959
|
135.42 pg/mL
Standard Deviation 57.855
|
114.04 pg/mL
Standard Deviation 70.658
|
101.12 pg/mL
Standard Deviation 56.853
|
142.23 pg/mL
Standard Deviation 165.924
|
106.43 pg/mL
Standard Deviation 28.244
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28
Change at Day 2 (n =9, 2, 5, 4, 6, 5, 6)
|
2.00 pg/mL
Standard Deviation 13.294
|
-60.64 pg/mL
Standard Deviation 16.913
|
-67.73 pg/mL
Standard Deviation 35.998
|
5.66 pg/mL
Standard Deviation 13.421
|
-20.14 pg/mL
Standard Deviation 41.966
|
-23.60 pg/mL
Standard Deviation 82.888
|
-47.52 pg/mL
Standard Deviation 19.664
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28
Change at Day 5 (n =9, 2, 5, 4, 6, 5, 6)
|
-3.25 pg/mL
Standard Deviation 13.506
|
-71.40 pg/mL
Standard Deviation 11.857
|
-80.65 pg/mL
Standard Deviation 66.445
|
4.33 pg/mL
Standard Deviation 12.213
|
-42.12 pg/mL
Standard Deviation 48.250
|
-53.40 pg/mL
Standard Deviation 125.815
|
-55.80 pg/mL
Standard Deviation 15.273
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28
Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4)
|
4.75 pg/mL
Standard Deviation 9.687
|
-70.50 pg/mL
Standard Deviation 14.007
|
-106.40 pg/mL
Standard Deviation 60.163
|
-1.92 pg/mL
Standard Deviation 24.123
|
-40.10 pg/mL
Standard Deviation 43.129
|
-96.67 pg/mL
Standard Deviation 134.176
|
-57.22 pg/mL
Standard Deviation 9.321
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28
Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4)
|
1.85 pg/mL
Standard Deviation 0.778
|
-54.25 pg/mL
Standard Deviation 23.972
|
-112.20 pg/mL
Standard Deviation 60.459
|
11.01 pg/mL
Standard Deviation 19.008
|
-37.56 pg/mL
Standard Deviation 47.031
|
-102.53 pg/mL
Standard Deviation 131.223
|
-37.95 pg/mL
Standard Deviation 24.957
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28
Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4)
|
2.85 pg/mL
Standard Deviation 11.102
|
18.30 pg/mL
Standard Deviation 34.748
|
-47.15 pg/mL
Standard Deviation 89.356
|
-14.59 pg/mL
Standard Deviation 21.736
|
-11.76 pg/mL
Standard Deviation 51.955
|
-62.07 pg/mL
Standard Deviation 94.378
|
8.48 pg/mL
Standard Deviation 23.010
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 2, 5, 7, 14, 21, 28, 29, 35, 56Population: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
Serum samples for IP-10 were analyzed using a validated analytical assay. Lower limit of quantification (LLOQ) for IP-10 was 10 pg/mL.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=14 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56
Baseline (n =9, 14, 7)
|
127.58 pg/mL
Standard Deviation 45.829
|
—
|
—
|
302.00 pg/mL
Standard Deviation 281.552
|
123.09 pg/mL
Standard Deviation 22.244
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56
Change at Day 2 (n =9, 14, 7)
|
-8.51 pg/mL
Standard Deviation 34.704
|
—
|
—
|
53.44 pg/mL
Standard Deviation 214.334
|
-49.57 pg/mL
Standard Deviation 35.759
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56
Change at Day 5 (n =9, 14, 7)
|
-33.93 pg/mL
Standard Deviation 33.465
|
—
|
—
|
-21.63 pg/mL
Standard Deviation 142.195
|
-49.01 pg/mL
Standard Deviation 35.998
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56
Change at Day 7 (n =9, 12, 7)
|
-31.31 pg/mL
Standard Deviation 32.203
|
—
|
—
|
-25.71 pg/mL
Standard Deviation 133.510
|
-52.50 pg/mL
Standard Deviation 42.216
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56
Change at Day 14 (n =9, 10, 6)
|
-52.06 pg/mL
Standard Deviation 24.663
|
—
|
—
|
-69.91 pg/mL
Standard Deviation 106.951
|
-68.55 pg/mL
Standard Deviation 28.524
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56
Change at Day 21 (n =9, 9, 5)
|
-51.47 pg/mL
Standard Deviation 28.094
|
—
|
—
|
-42.87 pg/mL
Standard Deviation 122.986
|
-46.64 pg/mL
Standard Deviation 27.340
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56
Change at Day 28 (n =8, 7, 5)
|
-46.19 pg/mL
Standard Deviation 35.893
|
—
|
—
|
-1.0 pg/mL
Standard Deviation 31.351
|
-53.36 pg/mL
Standard Deviation 19.771
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56
Change at Day 29 (n =8, 7, 5)
|
-37.50 pg/mL
Standard Deviation 31.849
|
—
|
—
|
-22.20 pg/mL
Standard Deviation 95.930
|
-49.34 pg/mL
Standard Deviation 14.306
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56
Change at Day 35 (n =8, 6, 5)
|
10.45 pg/mL
Standard Deviation 37.860
|
—
|
—
|
-69.54 pg/mL
Standard Deviation 124.165
|
110.68 pg/mL
Standard Deviation 108.041
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56
Change at Day 56 (n =7, 6, 4)
|
16.18 pg/mL
Standard Deviation 19.348
|
—
|
—
|
-31.71 pg/mL
Standard Deviation 67.158
|
167.85 pg/mL
Standard Deviation 201.780
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest.
Serum samples for hsCRP were analyzed using a validated analytical assay. Reference range for measurement of CRP was 0.015 to 2.0 mg/dL. LLOQ for hsCRP was 0.03 mg/dL and limit of detection was 0.015 mg/dL.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=7 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=13 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (SAD) Cohort: High Sensitivity C-reactive Protein (hsCRP) Concentration in Serum at Baseline
|
0.1066 milligram per deciliter (mg/dL)
Standard Deviation 0.09662
|
0.1158 milligram per deciliter (mg/dL)
Standard Deviation 0.20871
|
0.1710 milligram per deciliter (mg/dL)
Standard Deviation 0.10387
|
0.1220 milligram per deciliter (mg/dL)
Standard Deviation 0.11909
|
0.6420 milligram per deciliter (mg/dL)
Standard Deviation 1.41413
|
0.0757 milligram per deciliter (mg/dL)
Standard Deviation 0.04523
|
0.2290 milligram per deciliter (mg/dL)
Standard Deviation 0.11714
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 2, 5, 10, 11, 28Population: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
Serum samples for hsCRP were analyzed using a validated analytical assay. Reference range for measurement of CRP was 0.015 to 2.0 mg/dL. LLOQ for hsCRP was 0.03 mg/dL and limit of detection was 0.015 mg/dL.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=2 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=5 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=6 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28
Baseline (n= 9, 2, 5, 4, 6, 5, 6)
|
0.0815 mg/dL
Standard Deviation 0.08556
|
0.0746 mg/dL
Standard Deviation 0.02523
|
0.1902 mg/dL
Standard Deviation 0.06394
|
0.0974 mg/dL
Standard Deviation 0.06791
|
0.1002 mg/dL
Standard Deviation 0.11675
|
0.0983 mg/dL
Standard Deviation 0.03734
|
0.0505 mg/dL
Standard Deviation 0.02799
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28
Change at Day 2 (n= 9, 2, 5, 4, 6, 5, 6)
|
-0.0205 mg/dL
Standard Deviation 0.00071
|
-0.0298 mg/dL
Standard Deviation 0.01743
|
-0.0307 mg/dL
Standard Deviation 0.08168
|
-0.0148 mg/dL
Standard Deviation 0.03176
|
-0.0670 mg/dL
Standard Deviation 0.08196
|
-0.0408 mg/dL
Standard Deviation 0.03052
|
-0.0212 mg/dL
Standard Deviation 0.01712
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28
Change at Day 5 (n= 9, 2, 5, 4, 6, 5, 6)
|
-0.0050 mg/dL
Standard Deviation 0.02263
|
-0.0596 mg/dL
Standard Deviation 0.03345
|
-0.1078 mg/dL
Standard Deviation 0.05948
|
-0.0352 mg/dL
Standard Deviation 0.03847
|
-0.0972 mg/dL
Standard Deviation 0.11656
|
-0.0753 mg/dL
Standard Deviation 0.02269
|
-0.0435 mg/dL
Standard Deviation 0.02202
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28
Change at Day 10 (n= 9, 2, 5, 3, 6, 4, 4)
|
0.0015 mg/dL
Standard Deviation 0.00778
|
-0.0618 mg/dL
Standard Deviation 0.01445
|
-0.1838 mg/dL
Standard Deviation 0.04529
|
-0.0329 mg/dL
Standard Deviation 0.05656
|
-0.1002 mg/dL
Standard Deviation 0.11675
|
-0.0903 mg/dL
Standard Deviation 0.00961
|
-0.0467 mg/dL
Standard Deviation 0.02881
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28
Change at Day 11 (n= 9, 2, 5, 3, 6, 4, 4)
|
-0.0040 mg/dL
Standard Deviation 0.00990
|
-0.0615 mg/dL
Standard Deviation 0.01330
|
-0.1878 mg/dL
Standard Deviation 0.04136
|
-0.0186 mg/dL
Standard Deviation 0.07315
|
-0.1002 mg/dL
Standard Deviation 0.11675
|
-0.0870 mg/dL
Standard Deviation 0.00819
|
-0.0435 mg/dL
Standard Deviation 0.02849
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28
Change at Day 28 (n= 9, 2, 5, 3, 6, 4, 4)
|
0.0790 mg/dL
Standard Deviation 0.08910
|
-0.0275 mg/dL
Standard Deviation 0.04086
|
1.1255 mg/dL
Standard Deviation 1.63253
|
0.0496 mg/dL
Standard Deviation 0.18748
|
-0.0352 mg/dL
Standard Deviation 0.15033
|
0.0023 mg/dL
Standard Deviation 0.06001
|
0.0223 mg/dL
Standard Deviation 0.01556
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 2, 5 ,7,14, 21, 28, 29, 35, 56Population: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
Serum samples for hsCRP were analyzed using a validated analytical assay. Reference range for measurement of CRP was 0.015 to 2.0 mg/dL. LLOQ for hsCRP was 0.03 mg/dL and limit of detection was 0.015 mg/dL.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=14 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56
Baseline (n =9, 14, 7)
|
0.5694 mg/dL
Standard Deviation 1.11752
|
—
|
—
|
1.0699 mg/dL
Standard Deviation 1.39179
|
0.3143 mg/dL
Standard Deviation 0.34167
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56
Change at Day 2 (n =9, 14, 7)
|
-0.3408 mg/dL
Standard Deviation 0.86901
|
—
|
—
|
-0.1096 mg/dL
Standard Deviation 0.25370
|
-0.0189 mg/dL
Standard Deviation 0.14180
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56
Change at Day 5 (n =9, 14, 7)
|
-0.2413 mg/dL
Standard Deviation 1.45363
|
—
|
—
|
0.0204 mg/dL
Standard Deviation 0.51424
|
-0.2119 mg/dL
Standard Deviation 0.27245
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56
Change at Day 7 (n =9, 12, 7)
|
-0.1573 mg/dL
Standard Deviation 1.90640
|
—
|
—
|
0.1958 mg/dL
Standard Deviation 0.85725
|
-0.1983 mg/dL
Standard Deviation 0.31021
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56
Change at Day 14 (n =9, 10, 6)
|
-0.1910 mg/dL
Standard Deviation 0.65215
|
—
|
—
|
0.4118 mg/dL
Standard Deviation 1.19190
|
-0.2582 mg/dL
Standard Deviation 0.33762
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56
Change at Day 21 (n =9, 9, 5)
|
-0.3067 mg/dL
Standard Deviation 0.61035
|
—
|
—
|
-0.1397 mg/dL
Standard Deviation 0.46958
|
-0.2716 mg/dL
Standard Deviation 0.38954
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56
Change at Day 28 (n =8, 7, 5)
|
-0.3549 mg/dL
Standard Deviation 0.69576
|
—
|
—
|
-0.4075 mg/dL
Standard Deviation 0.37814
|
-0.2670 mg/dL
Standard Deviation 0.37674
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56
Change at Day 29 (n =8, 7, 5)
|
-0.3533 mg/dL
Standard Deviation 0.69589
|
—
|
—
|
-0.6113 mg/dL
Standard Deviation 0.79373
|
-0.2626 mg/dL
Standard Deviation 0.34387
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56
Change at Day 35 (n =8, 6, 5)
|
-0.2533 mg/dL
Standard Deviation 0.79446
|
—
|
—
|
-0.5945 mg/dL
Standard Deviation 0.78042
|
0.7546 mg/dL
Standard Deviation 1.07215
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56
Change at Day 56 (n =7, 6, 4)
|
-0.2662 mg/dL
Standard Deviation 0.78307
|
—
|
—
|
-0.3407 mg/dL
Standard Deviation 0.45280
|
0.2533 mg/dL
Standard Deviation 0.82107
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 2, 5, 8Population: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=7 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=13 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8
Baseline (n =13, 7, 6, 6, 6, 8, 8)
|
2.433 cells per millimeter cube (cells/mm^3)
Standard Deviation 1.0574
|
2.973 cells per millimeter cube (cells/mm^3)
Standard Deviation 1.2374
|
2.858 cells per millimeter cube (cells/mm^3)
Standard Deviation 0.6901
|
2.988 cells per millimeter cube (cells/mm^3)
Standard Deviation 1.2090
|
3.097 cells per millimeter cube (cells/mm^3)
Standard Deviation 1.1903
|
2.500 cells per millimeter cube (cells/mm^3)
Standard Deviation 0.6782
|
3.048 cells per millimeter cube (cells/mm^3)
Standard Deviation 0.7552
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8
Change at Day 2 (n =13, 7, 6, 6, 6, 8, 8)
|
0.340 cells per millimeter cube (cells/mm^3)
Standard Deviation 0.6643
|
-0.315 cells per millimeter cube (cells/mm^3)
Standard Deviation 0.8594
|
-0.760 cells per millimeter cube (cells/mm^3)
Standard Deviation 0.5266
|
0.096 cells per millimeter cube (cells/mm^3)
Standard Deviation 0.7459
|
0.377 cells per millimeter cube (cells/mm^3)
Standard Deviation 0.7133
|
0.285 cells per millimeter cube (cells/mm^3)
Standard Deviation 0.3214
|
0.240 cells per millimeter cube (cells/mm^3)
Standard Deviation 0.7344
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8
Change at Day 5 (n =13, 6, 6, 6, 5, 8, 8)
|
0.280 cells per millimeter cube (cells/mm^3)
Standard Deviation 0.5187
|
0.296 cells per millimeter cube (cells/mm^3)
Standard Deviation 0.3849
|
0.654 cells per millimeter cube (cells/mm^3)
Standard Deviation 0.6930
|
0.047 cells per millimeter cube (cells/mm^3)
Standard Deviation 0.8048
|
-0.162 cells per millimeter cube (cells/mm^3)
Standard Deviation 1.1032
|
-0.170 cells per millimeter cube (cells/mm^3)
Standard Deviation 0.2265
|
-0.170 cells per millimeter cube (cells/mm^3)
Standard Deviation 0.6963
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8
Change at Day 8 (n =12, 5, 6, 6, 5, 8, 8)
|
0.196 cells per millimeter cube (cells/mm^3)
Standard Deviation 0.1674
|
-0.110 cells per millimeter cube (cells/mm^3)
Standard Deviation 0.7910
|
1.188 cells per millimeter cube (cells/mm^3)
Standard Deviation 1.8134
|
-0.245 cells per millimeter cube (cells/mm^3)
Standard Deviation 0.7834
|
0.017 cells per millimeter cube (cells/mm^3)
Standard Deviation 1.1173
|
-0.293 cells per millimeter cube (cells/mm^3)
Standard Deviation 0.3100
|
-0.058 cells per millimeter cube (cells/mm^3)
Standard Deviation 0.9051
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 4, 8, 10, 11, 14, 28Population: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=2 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=5 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=6 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28
Baseline (n =9, 2, 5, 4, 6, 5, 6)
|
2.340 cells/mm^3
Standard Deviation 0.2970
|
2.690 cells/mm^3
Standard Deviation 0.9337
|
3.217 cells/mm^3
Standard Deviation 0.9677
|
2.584 cells/mm^3
Standard Deviation 0.8858
|
2.676 cells/mm^3
Standard Deviation 0.6726
|
2.770 cells/mm^3
Standard Deviation 0.4907
|
2.710 cells/mm^3
Standard Deviation 1.0372
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28
Change at Day 4 (n =9, 2, 5, 4, 6, 5, 6)
|
0.060 cells/mm^3
Standard Deviation 0.0283
|
-0.980 cells/mm^3
Standard Deviation 0.3726
|
-0.902 cells/mm^3
Standard Deviation 2.0680
|
0.099 cells/mm^3
Standard Deviation 0.4191
|
-0.242 cells/mm^3
Standard Deviation 1.1533
|
-0.215 cells/mm^3
Standard Deviation 0.6376
|
-0.295 cells/mm^3
Standard Deviation 0.8000
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28
Change at Day 8 (n =9, 2, 5, 4, 6, 4, 5)
|
0.635 cells/mm^3
Standard Deviation 1.1526
|
-0.913 cells/mm^3
Standard Deviation 0.4039
|
-1.702 cells/mm^3
Standard Deviation 1.3292
|
0.239 cells/mm^3
Standard Deviation 0.5725
|
-0.296 cells/mm^3
Standard Deviation 0.7032
|
-0.178 cells/mm^3
Standard Deviation 0.5160
|
-0.793 cells/mm^3
Standard Deviation 0.5720
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28
Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4)
|
0.635 cells/mm^3
Standard Deviation 1.0394
|
-1.168 cells/mm^3
Standard Deviation 0.4197
|
-2.125 cells/mm^3
Standard Deviation 1.2878
|
0.156 cells/mm^3
Standard Deviation 0.5860
|
-0.340 cells/mm^3
Standard Deviation 0.8602
|
0.327 cells/mm^3
Standard Deviation 0.8228
|
-1.012 cells/mm^3
Standard Deviation 0.5365
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28
Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4)
|
0.400 cells/mm^3
Standard Deviation 1.2021
|
-0.248 cells/mm^3
Standard Deviation 0.3976
|
-2.010 cells/mm^3
Standard Deviation 1.3075
|
0.158 cells/mm^3
Standard Deviation 0.4996
|
-0.382 cells/mm^3
Standard Deviation 0.8244
|
0.260 cells/mm^3
Standard Deviation 0.7572
|
-0.280 cells/mm^3
Standard Deviation 0.9159
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28
Change at Day 14 (n =9, 2, 5, 3, 6, 4, 4)
|
0.385 cells/mm^3
Standard Deviation 0.8273
|
0.228 cells/mm^3
Standard Deviation 0.3377
|
0.290 cells/mm^3
Standard Deviation 1.0943
|
-0.020 cells/mm^3
Standard Deviation 0.5471
|
-0.060 cells/mm^3
Standard Deviation 0.8663
|
0.650 cells/mm^3
Standard Deviation 0.8543
|
0.232 cells/mm^3
Standard Deviation 0.4395
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28
Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4)
|
0.130 cells/mm^3
Standard Deviation 0.4525
|
0.050 cells/mm^3
Standard Deviation 0.6249
|
0.298 cells/mm^3
Standard Deviation 0.3777
|
0.030 cells/mm^3
Standard Deviation 0.4649
|
-0.012 cells/mm^3
Standard Deviation 1.1401
|
0.697 cells/mm^3
Standard Deviation 0.0839
|
-0.055 cells/mm^3
Standard Deviation 0.4578
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 4, 6 ,8,10, 13, 14, 21, 28, 35, 42, 56Population: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=14 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Baseline (n =9, 14, 7)
|
3.640 cells/mm^3
Standard Deviation 1.4997
|
—
|
—
|
4.109 cells/mm^3
Standard Deviation 1.4401
|
3.909 cells/mm^3
Standard Deviation 1.1841
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 4 (n =9, 14, 7)
|
0.006 cells/mm^3
Standard Deviation 1.1696
|
—
|
—
|
-0.402 cells/mm^3
Standard Deviation 0.9308
|
0.153 cells/mm^3
Standard Deviation 0.7114
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 6 (n =9, 14, 7)
|
-0.073 cells/mm^3
Standard Deviation 0.8229
|
—
|
—
|
-0.209 cells/mm^3
Standard Deviation 1.2224
|
-0.303 cells/mm^3
Standard Deviation 0.6058
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 8 (n =9, 12, 7)
|
0.013 cells/mm^3
Standard Deviation 1.2572
|
—
|
—
|
-0.473 cells/mm^3
Standard Deviation 0.6962
|
-0.973 cells/mm^3
Standard Deviation 0.4394
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 10 (n =9, 10, 7)
|
0.197 cells/mm^3
Standard Deviation 1.1099
|
—
|
—
|
-0.463 cells/mm^3
Standard Deviation 0.7834
|
-1.299 cells/mm^3
Standard Deviation 0.6906
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 13 (n =9, 10, 6)
|
-0.297 cells/mm^3
Standard Deviation 1.2264
|
—
|
—
|
-0.654 cells/mm^3
Standard Deviation 0.7847
|
-1.538 cells/mm^3
Standard Deviation 0.9097
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 14 (n =9, 10, 6)
|
-0.146 cells/mm^3
Standard Deviation 1.1226
|
—
|
—
|
-0.247 cells/mm^3
Standard Deviation 0.9682
|
-1.465 cells/mm^3
Standard Deviation 0.9517
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 21 (n =9, 9, 5)
|
-0.638 cells/mm^3
Standard Deviation 0.9404
|
—
|
—
|
-0.762 cells/mm^3
Standard Deviation 0.7389
|
-1.410 cells/mm^3
Standard Deviation 1.2572
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 28 (n =8, 7, 5)
|
-0.890 cells/mm^3
Standard Deviation 0.9952
|
—
|
—
|
-0.678 cells/mm^3
Standard Deviation 0.6416
|
-1.450 cells/mm^3
Standard Deviation 1.1195
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 35 (n =8, 6, 5)
|
-0.777 cells/mm^3
Standard Deviation 1.1154
|
—
|
—
|
-0.081 cells/mm^3
Standard Deviation 1.4496
|
-1.008 cells/mm^3
Standard Deviation 0.8082
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 42 (n =7, 6, 4)
|
-0.677 cells/mm^3
Standard Deviation 1.1209
|
—
|
—
|
-0.427 cells/mm^3
Standard Deviation 0.6004
|
-1.050 cells/mm^3
Standard Deviation 0.6868
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 56 (n =7, 6, 4)
|
-0.533 cells/mm^3
Standard Deviation 1.3025
|
—
|
—
|
-0.036 cells/mm^3
Standard Deviation 0.7864
|
-0.493 cells/mm^3
Standard Deviation 1.6373
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 2, 5, 8Population: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=7 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=8 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=13 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8
Baseline (n =13, 7, 6, 6, 6, 8, 8)
|
1.19 cells/mm^3
Standard Deviation 0.380
|
1.44 cells/mm^3
Standard Deviation 0.825
|
1.20 cells/mm^3
Standard Deviation 0.524
|
1.23 cells/mm^3
Standard Deviation 0.470
|
0.98 cells/mm^3
Standard Deviation 0.279
|
1.25 cells/mm^3
Standard Deviation 0.243
|
1.25 cells/mm^3
Standard Deviation 0.327
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8
Change at Day 2 (n =13, 7, 6, 6, 6, 8, 8)
|
-0.09 cells/mm^3
Standard Deviation 0.135
|
-0.14 cells/mm^3
Standard Deviation 0.177
|
-0.16 cells/mm^3
Standard Deviation 0.177
|
0.02 cells/mm^3
Standard Deviation 0.152
|
-0.02 cells/mm^3
Standard Deviation 0.160
|
-0.15 cells/mm^3
Standard Deviation 0.138
|
0.02 cells/mm^3
Standard Deviation 0.256
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8
Change at Day 5 (n =13, 6, 6, 6, 5, 8, 8)
|
0.07 cells/mm^3
Standard Deviation 0.175
|
-0.23 cells/mm^3
Standard Deviation 0.459
|
-0.15 cells/mm^3
Standard Deviation 0.193
|
0.04 cells/mm^3
Standard Deviation 0.194
|
-0.05 cells/mm^3
Standard Deviation 0.138
|
-0.27 cells/mm^3
Standard Deviation 0.103
|
0.02 cells/mm^3
Standard Deviation 0.409
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8
Change at Day 8 (n =12, 5, 6, 6, 5, 8, 8)
|
0.04 cells/mm^3
Standard Deviation 0.114
|
-0.26 cells/mm^3
Standard Deviation 0.478
|
-0.14 cells/mm^3
Standard Deviation 0.346
|
0.03 cells/mm^3
Standard Deviation 0.234
|
0.03 cells/mm^3
Standard Deviation 0.242
|
-0.15 cells/mm^3
Standard Deviation 0.226
|
0.34 cells/mm^3
Standard Deviation 0.532
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 4, 8, 10, 11, 14, 28Population: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=2 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=5 Participants
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
n=6 Participants
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=5 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 Participants
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 Participants
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28
Baseline (n =9, 2, 5, 4, 6, 5, 6)
|
0.85 cells/mm^3
Standard Deviation 0.212
|
2.26 cells/mm^3
Standard Deviation 0.550
|
1.38 cells/mm^3
Standard Deviation 0.286
|
1.26 cells/mm^3
Standard Deviation 0.490
|
1.22 cells/mm^3
Standard Deviation 0.363
|
1.03 cells/mm^3
Standard Deviation 0.350
|
1.40 cells/mm^3
Standard Deviation 0.410
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28
Change at Day 4 (n =9, 2, 5, 4, 6, 5, 6)
|
0.05 cells/mm^3
Standard Deviation 0.071
|
-0.54 cells/mm^3
Standard Deviation 0.241
|
-0.32 cells/mm^3
Standard Deviation 0.223
|
-0.03 cells/mm^3
Standard Deviation 0.212
|
-0.10 cells/mm^3
Standard Deviation 0.071
|
0.05 cells/mm^3
Standard Deviation 0.129
|
-0.18 cells/mm^3
Standard Deviation 0.306
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28
Change at Day 8 (n =9, 2, 5, 4, 6, 4, 5)
|
0.30 cells/mm^3
Standard Deviation 0.283
|
-1.28 cells/mm^3
Standard Deviation 0.395
|
-0.90 cells/mm^3
Standard Deviation 0.187
|
-0.11 cells/mm^3
Standard Deviation 0.285
|
-0.20 cells/mm^3
Standard Deviation 0.100
|
-0.13 cells/mm^3
Standard Deviation 0.250
|
-0.60 cells/mm^3
Standard Deviation 0.210
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28
Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4)
|
0.20 cells/mm^3
Standard Deviation 0.283
|
-1.48 cells/mm^3
Standard Deviation 0.403
|
-0.93 cells/mm^3
Standard Deviation 0.206
|
-0.19 cells/mm^3
Standard Deviation 0.398
|
-0.24 cells/mm^3
Standard Deviation 0.089
|
-0.07 cells/mm^3
Standard Deviation 0.231
|
-0.70 cells/mm^3
Standard Deviation 0.352
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28
Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4)
|
0.30 cells/mm^3
Standard Deviation 0.424
|
-1.43 cells/mm^3
Standard Deviation 0.499
|
-0.93 cells/mm^3
Standard Deviation 0.330
|
-0.13 cells/mm^3
Standard Deviation 0.343
|
-0.34 cells/mm^3
Standard Deviation 0.089
|
-0.23 cells/mm^3
Standard Deviation 0.115
|
-0.72 cells/mm^3
Standard Deviation 0.354
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28
Change at Day 14 (n =9, 2, 5, 3, 6, 4, 4)
|
0.05 cells/mm^3
Standard Deviation 0.495
|
-1.10 cells/mm^3
Standard Deviation 0.408
|
-0.90 cells/mm^3
Standard Deviation 0.183
|
-0.12 cells/mm^3
Standard Deviation 0.393
|
-0.22 cells/mm^3
Standard Deviation 0.110
|
0.03 cells/mm^3
Standard Deviation 0.058
|
-0.60 cells/mm^3
Standard Deviation 0.297
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28
Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4)
|
-0.05 cells/mm^3
Standard Deviation 0.212
|
0.18 cells/mm^3
Standard Deviation 0.189
|
0.33 cells/mm^3
Standard Deviation 0.479
|
0.11 cells/mm^3
Standard Deviation 0.431
|
0.22 cells/mm^3
Standard Deviation 0.277
|
0.30 cells/mm^3
Standard Deviation 0.346
|
0.65 cells/mm^3
Standard Deviation 0.619
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 4, 6 ,8,10, 13, 14, 21, 28, 35, 42, 56Population: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
Outcome measures
| Measure |
Placebo: Twice Daily MAD Cohort
n=14 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 200 mg SAD Cohort
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=9 Participants
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=7 Participants
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: Once Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
Placebo: MAD Psoriasis Cohort
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Baseline (n =9, 14, 7)
|
1.45 cells/mm^3
Standard Deviation 0.285
|
—
|
—
|
1.49 cells/mm^3
Standard Deviation 0.355
|
1.31 cells/mm^3
Standard Deviation 0.393
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 4 (n =9, 14, 7)
|
-0.09 cells/mm^3
Standard Deviation 0.207
|
—
|
—
|
-0.10 cells/mm^3
Standard Deviation 0.300
|
-0.13 cells/mm^3
Standard Deviation 0.281
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 6 (n =9, 14, 7)
|
-0.16 cells/mm^3
Standard Deviation 0.250
|
—
|
—
|
-0.09 cells/mm^3
Standard Deviation 0.392
|
-0.27 cells/mm^3
Standard Deviation 0.373
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 8 (n =9, 12, 7)
|
-0.21 cells/mm^3
Standard Deviation 0.243
|
—
|
—
|
-0.20 cells/mm^3
Standard Deviation 0.430
|
-0.59 cells/mm^3
Standard Deviation 0.353
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 10 (n =9, 10, 7)
|
-0.35 cells/mm^3
Standard Deviation 0.295
|
—
|
—
|
-0.21 cells/mm^3
Standard Deviation 0.355
|
-0.70 cells/mm^3
Standard Deviation 0.361
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 13 (n =9, 10, 6)
|
-0.41 cells/mm^3
Standard Deviation 0.373
|
—
|
—
|
-0.20 cells/mm^3
Standard Deviation 0.354
|
-0.75 cells/mm^3
Standard Deviation 0.459
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 14 (n =9, 10, 6)
|
-0.34 cells/mm^3
Standard Deviation 0.392
|
—
|
—
|
-0.13 cells/mm^3
Standard Deviation 0.371
|
-0.82 cells/mm^3
Standard Deviation 0.462
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 21 (n =9, 9, 5)
|
-0.27 cells/mm^3
Standard Deviation 0.430
|
—
|
—
|
-0.22 cells/mm^3
Standard Deviation 0.393
|
-0.66 cells/mm^3
Standard Deviation 0.270
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 28 (n =8, 7, 5)
|
-0.36 cells/mm^3
Standard Deviation 0.264
|
—
|
—
|
-0.24 cells/mm^3
Standard Deviation 0.487
|
-0.60 cells/mm^3
Standard Deviation 0.255
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 35 (n =8, 6, 5)
|
-0.03 cells/mm^3
Standard Deviation 0.163
|
—
|
—
|
0.26 cells/mm^3
Standard Deviation 0.498
|
0.22 cells/mm^3
Standard Deviation 0.228
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 42 (n =7, 6, 4)
|
0.33 cells/mm^3
Standard Deviation 0.427
|
—
|
—
|
0.46 cells/mm^3
Standard Deviation 0.431
|
1.35 cells/mm^3
Standard Deviation 0.551
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Change at Day 56 (n =7, 6, 4
|
0.07 cells/mm^3
Standard Deviation 0.250
|
—
|
—
|
0.13 cells/mm^3
Standard Deviation 0.335
|
0.50 cells/mm^3
Standard Deviation 0.183
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo: SAD Cohort
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo: Once Daily MAD Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo: Twice Daily MAD Cohort
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo: MAD Psoriasis Cohort
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF--06700841: 1 Milligram (mg) SAD Cohort
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PF--06700841: 3 mg SAD Cohort
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PF-06700841: 10 mg SAD Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PF-06700841: 10 mg Once Daily MAD Cohort
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-06700841: 30 mg SAD Cohort
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PF-06700841: 30 mg Once Daily MAD Cohort
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-06700841: 100 mg SAD Cohort
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-06700841: 100 mg Once Daily MAD Cohort
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-06700841: 50 mg Twice Daily MAD Cohort
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-06700841: 200 mg SAD Cohort
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-06700841: 175 mg Once Daily MAD Cohort
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-06700841: 30 mg MAD Psoriasis Cohort
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
PF-06700841: 100 mg MAD Psoriasis Cohort
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo: SAD Cohort
n=13 participants at risk
Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
Placebo: Once Daily MAD Cohort
n=9 participants at risk
Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
|
Placebo: Twice Daily MAD Cohort
n=2 participants at risk
Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
Placebo: MAD Psoriasis Cohort
n=9 participants at risk
Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF--06700841: 1 Milligram (mg) SAD Cohort
n=7 participants at risk
Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF--06700841: 3 mg SAD Cohort
n=6 participants at risk
Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 10 mg SAD Cohort
n=6 participants at risk
Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 10 mg Once Daily MAD Cohort
n=5 participants at risk
Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg SAD Cohort
n=6 participants at risk
Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 30 mg Once Daily MAD Cohort
n=4 participants at risk
Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 100 mg SAD Cohort
n=8 participants at risk
Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 100 mg Once Daily MAD Cohort
n=6 participants at risk
Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 50 mg Twice Daily MAD Cohort
n=5 participants at risk
Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
|
PF-06700841: 200 mg SAD Cohort
n=8 participants at risk
Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
|
PF-06700841: 175 mg Once Daily MAD Cohort
n=6 participants at risk
Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
|
PF-06700841: 30 mg MAD Psoriasis Cohort
n=14 participants at risk
Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg MAD Psoriasis Cohort
n=7 participants at risk
Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
|
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)
n=12 participants at risk
All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)
n=12 participants at risk
All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)
n=12 participants at risk
All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
16.7%
1/6
|
0.00%
0/14
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Cardiac disorders
Palpitations
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/14
|
14.3%
1/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Ear and labyrinth disorders
Vertigo
|
7.7%
1/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
33.3%
3/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
12.5%
1/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
16.7%
1/6
|
21.4%
3/14
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/7
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/12
|
|
Gastrointestinal disorders
Toothache
|
7.7%
1/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Nodule
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/14
|
14.3%
1/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/14
|
14.3%
1/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/7
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Investigations
Blood creatinine increased
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/6
|
25.0%
1/4
|
12.5%
1/8
|
16.7%
1/6
|
80.0%
4/5
|
12.5%
1/8
|
66.7%
4/6
|
50.0%
7/14
|
85.7%
6/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/14
|
14.3%
1/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
40.0%
2/5
|
0.00%
0/8
|
16.7%
1/6
|
7.1%
1/14
|
14.3%
1/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Investigations
White blood cell count decreased
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/14
|
14.3%
1/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
12.5%
1/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Nervous system disorders
Headache
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
16.7%
1/6
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/6
|
7.1%
1/14
|
14.3%
1/7
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/12
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/14
|
14.3%
1/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Nervous system disorders
Presyncope
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
25.0%
1/4
|
12.5%
1/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Nervous system disorders
Syncope
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
7.1%
1/14
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/13
|
0.00%
0/9
|
50.0%
1/2
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/14
|
14.3%
1/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Vascular disorders
Flushing
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/14
|
14.3%
1/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
|
Vascular disorders
Haematoma
|
0.00%
0/13
|
0.00%
0/9
|
0.00%
0/2
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
16.7%
1/6
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER