Trial Outcomes & Findings for Study of Single and Multiple Ascending Doses of PF-07059013 in Healthy Adult Participants (NCT NCT04323124)
NCT ID: NCT04323124
Last Updated: 2024-09-19
Results Overview
Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Treatment-related TEAEs were any untoward medical occurrence attributed to study intervention. Relatedness to study treatment was determined by the investigator. Duration of participation of Part 1 and Part 3, from the screening visit to the follow-up phone call, was approximately 15 weeks. Duration of participation of Part 2, from the screening visit to the follow-up phone call, was approximately 10 weeks.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
61 participants
Primary outcome timeframe
Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2)
Results posted on
2024-09-19
Participant Flow
A total of 61 participants were randomized in the study and all were treated with study intervention. For Part 1, a total of 21 participants were randomized and all were treated with at least 1 dose. For Part 2, a total of 35 participants were randomized and treated. For Part 3, a total of 5 participants were randomized and all were treated with at least 1 dose.
Participant milestones
| Measure |
A->D->F->H
In Part 1, participants were given a single dose of each study intervention assigned.
A-\>D-\>F-\>H: Placebo Single dose (SD) Polymer-\>PF-07059013 500 mg SD Polymer-\>PF-07059013 2000 mg SD Polymer-\>PF-07059013 2000 mg SD without (w/o) Polymer
|
A->E->G->I
In Part 1, participants were given a single dose of each study intervention assigned.
A-\>E-\>G-\>I: Placebo SD Polymer-\>PF-07059013 1000 mg SD Polymer-\>PF-07059013 3000 mg SD Polymer-\>PF-07059013 3000 mg SD w/o Polymer
|
B->A->F->H
In Part 1, participants were given a single dose of each study intervention assigned.
B-\>A-\>F-\>H: PF-07059013 100 mg SD Polymer-\>Placebo SD Polymer-\>PF-07059013 2000 mg SD Polymer-\>PF-07059013 2000 mg SD w/o Polymer
|
B->D->A->H
In Part 1, participants were given a single dose of each study intervention assigned.
B-\>D-\>A-\>H: PF-07059013 100 mg SD Polymer-\>PF-07059013 500 mg SD Polymer-\>Placebo SD Polymer-\>PF-07059013 2000 mg SD w/o Polymer
|
C->A->G->I
In Part 1, participants were given a single dose of each study intervention assigned.
C-\>A-\>G-\>I: PF-07059013 250 mg SD Polymer-\>Placebo SD Polymer-\>PF-07059013 3000 mg SD Polymer-\>PF-07059013 3000 mg SD w/o Polymer
|
C->E->A->I
In Part 1, participants were given a single dose of each study intervention assigned.
C-\>E-\>A-\>I: PF-07059013 250 mg SD Polymer-\>PF-07059013 1000 mg SD Polymer-\>Placebo SD Polymer-\>PF-07059013 3000 mg SD w/o Polymer
|
Placebo MD
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days.
|
PF-07059013 800 mg MD
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days.
|
PF-07059013 1600 mg MD
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days.
|
PF-07059013 3000 mg MD
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days.
|
PF-07059013 4000 mg MD
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days.
|
P->Q->R->S
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions. The presence/absence of polymer is utilized to select the preferred formulation composition.
P-\>Q-\>R-\>S:Suspension Fasted Polymer (Small Particle Size)-\>Tablet Fasted w/o Polymer-\>Suspension Fed Polymer (Small Particle Size)-\>Suspension Fasted Polymer (Moderate Particle Size)
|
P->Q->S->R
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions. The presence/absence of polymer is utilized to select the preferred formulation composition.
P-\>Q-\>S-\>R: Suspension Fasted Polymer (Small Particle Size)-\>Tablet Fasted w/o Polymer-\>Suspension Fasted Polymer (Moderate Particle Size)-\>Suspension Fed Polymer (Small Particle Size)
|
Q->P->R->S
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions. The presence/absence of polymer is utilized to select the preferred formulation composition.
Q-\>P-\>R-\>S: Tablet Fasted w/o Polymer-\>Suspension Fasted Polymer (Small Particle Size)-\>Suspension Fed Polymer (Small Particle Size)-\>Suspension Fasted Polymer (Moderate Particle Size)
|
Q->P->S->R
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions. The presence/absence of polymer is utilized to select the preferred formulation composition.
Q-\>P-\>S-\>R: Tablet Fasted w/o Polymer-\>Suspension Fasted Polymer (Small Particle Size)-\>Suspension Fasted Polymer (Moderate Particle Size)-\>Suspension Fed Polymer (Small Particle Size)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
5
|
4
|
8
|
8
|
7
|
6
|
6
|
2
|
1
|
1
|
1
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
2
|
8
|
6
|
5
|
6
|
6
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
2
|
2
|
0
|
2
|
2
|
0
|
0
|
2
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
A->D->F->H
In Part 1, participants were given a single dose of each study intervention assigned.
A-\>D-\>F-\>H: Placebo Single dose (SD) Polymer-\>PF-07059013 500 mg SD Polymer-\>PF-07059013 2000 mg SD Polymer-\>PF-07059013 2000 mg SD without (w/o) Polymer
|
A->E->G->I
In Part 1, participants were given a single dose of each study intervention assigned.
A-\>E-\>G-\>I: Placebo SD Polymer-\>PF-07059013 1000 mg SD Polymer-\>PF-07059013 3000 mg SD Polymer-\>PF-07059013 3000 mg SD w/o Polymer
|
B->A->F->H
In Part 1, participants were given a single dose of each study intervention assigned.
B-\>A-\>F-\>H: PF-07059013 100 mg SD Polymer-\>Placebo SD Polymer-\>PF-07059013 2000 mg SD Polymer-\>PF-07059013 2000 mg SD w/o Polymer
|
B->D->A->H
In Part 1, participants were given a single dose of each study intervention assigned.
B-\>D-\>A-\>H: PF-07059013 100 mg SD Polymer-\>PF-07059013 500 mg SD Polymer-\>Placebo SD Polymer-\>PF-07059013 2000 mg SD w/o Polymer
|
C->A->G->I
In Part 1, participants were given a single dose of each study intervention assigned.
C-\>A-\>G-\>I: PF-07059013 250 mg SD Polymer-\>Placebo SD Polymer-\>PF-07059013 3000 mg SD Polymer-\>PF-07059013 3000 mg SD w/o Polymer
|
C->E->A->I
In Part 1, participants were given a single dose of each study intervention assigned.
C-\>E-\>A-\>I: PF-07059013 250 mg SD Polymer-\>PF-07059013 1000 mg SD Polymer-\>Placebo SD Polymer-\>PF-07059013 3000 mg SD w/o Polymer
|
Placebo MD
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days.
|
PF-07059013 800 mg MD
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days.
|
PF-07059013 1600 mg MD
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days.
|
PF-07059013 3000 mg MD
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days.
|
PF-07059013 4000 mg MD
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days.
|
P->Q->R->S
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions. The presence/absence of polymer is utilized to select the preferred formulation composition.
P-\>Q-\>R-\>S:Suspension Fasted Polymer (Small Particle Size)-\>Tablet Fasted w/o Polymer-\>Suspension Fed Polymer (Small Particle Size)-\>Suspension Fasted Polymer (Moderate Particle Size)
|
P->Q->S->R
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions. The presence/absence of polymer is utilized to select the preferred formulation composition.
P-\>Q-\>S-\>R: Suspension Fasted Polymer (Small Particle Size)-\>Tablet Fasted w/o Polymer-\>Suspension Fasted Polymer (Moderate Particle Size)-\>Suspension Fed Polymer (Small Particle Size)
|
Q->P->R->S
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions. The presence/absence of polymer is utilized to select the preferred formulation composition.
Q-\>P-\>R-\>S: Tablet Fasted w/o Polymer-\>Suspension Fasted Polymer (Small Particle Size)-\>Suspension Fed Polymer (Small Particle Size)-\>Suspension Fasted Polymer (Moderate Particle Size)
|
Q->P->S->R
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions. The presence/absence of polymer is utilized to select the preferred formulation composition.
Q-\>P-\>S-\>R: Tablet Fasted w/o Polymer-\>Suspension Fasted Polymer (Small Particle Size)-\>Suspension Fasted Polymer (Moderate Particle Size)-\>Suspension Fed Polymer (Small Particle Size)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Coming from a red zone (COVID)
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
No longer meets eligibility criteria
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Study terminated by sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
0
|
Baseline Characteristics
Study of Single and Multiple Ascending Doses of PF-07059013 in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
A->D->F->H
n=3 Participants
In Part 1, participants were given a single dose of study intervention assigned.
A-\>D-\>F-\>H: Placebo Single dose (SD) Polymer-\>PF-07059013 500 mg SD Polymer-\>PF-07059013 2000 mg SD Polymer-\>PF-07059013 2000 mg SD without (w/o) Polymer
|
A->E->G->I
n=3 Participants
In Part 1, participants were given a single dose of study intervention assigned.
A-\>E-\>G-\>I: Placebo SD Polymer-\>PF-07059013 1000 mg SD Polymer-\>PF-07059013 3000 mg SD Polymer-\>PF-07059013 3000 mg SD w/o Polymer
|
B->A->F->H
n=3 Participants
In Part 1, participants were given a single dose of study intervention assigned.
B-\>A-\>F-\>H: PF-07059013 100 mg SD Polymer-\>Placebo SD Polymer-\>PF-07059013 2000 mg SD Polymer-\>PF-07059013 2000 mg SD w/o Polymer
|
B->D->A->H
n=3 Participants
In Part 1, participants were given a single dose of study intervention assigned.
B-\>D-\>A-\>H: PF-07059013 100 mg SD Polymer-\>PF-07059013 500 mg SD Polymer-\>Placebo SD Polymer-\>PF-07059013 2000 mg SD w/o Polymer
|
C->A->G->I
n=5 Participants
In Part 1, participants were given a single dose of study intervention assigned.
C-\>A-\>G-\>I: PF-07059013 250 mg SD Polymer-\>Placebo SD Polymer-\>PF-07059013 3000 mg SD Polymer-\>PF-07059013 3000 mg SD w/o Polymer
|
C->E->A->I
n=4 Participants
In Part 1, participants were given a single dose of study intervention assigned.
C-\>E-\>A-\>I: PF-07059013 250 mg SD Polymer-\>PF-07059013 1000 mg SD Polymer-\>Placebo SD Polymer-\>PF-07059013 3000 mg SD w/o Polymer
|
Part 2: Placebo MD With Polymer
n=8 Participants
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 800 mg MD With Polymer
n=8 Participants
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 1600 mg MD With Polymer
n=7 Participants
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 3000 mg MD With Polymer
n=6 Participants
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 4000 mg MD With Polymer
n=6 Participants
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
P->Q->R->S
n=2 Participants
In Part 3, participants were given a single dose of study intervention assigned under fed or fasted conditions.
P-\>Q-\>R-\>S: Suspension Fasted Polymer (Small Particle Size)-\>Tablet Fasted w/o Polymer-\>Suspension Fed Polymer (Small Particle Size)-\>Suspension Fasted Polymer (Moderate Particle Size)
|
P->Q->S->R
n=1 Participants
In Part 3, participants were given a single dose of study intervention assigned under fed or fasted conditions.
P-\>Q-\>S-\>R: Suspension Fasted Polymer (Small Particle Size)-\>Tablet Fasted w/o Polymer-\>Suspension Fasted Polymer (Moderate Particle Size)-\>Suspension Fed Polymer (Small Particle Size)
|
Q->P->R->S
n=1 Participants
In Part 3, participants were given a single dose of study intervention assigned under fed or fasted conditions.
Q-\>P-\>R-\>S: Tablet Fasted w/o Polymer-\>Suspension Fasted Polymer (Small Particle Size)-\>Suspension Fed Polymer (Small Particle Size)-\>Suspension Fasted Polymer (Moderate Particle Size)
|
Q->P->S->R
n=1 Participants
In Part 3, participants were given a single dose of study intervention assigned under fed or fasted conditions.
Q-\>P-\>S-\>R: Tablet Fasted w/o Polymer-\>Suspension Fasted Polymer (Small Particle Size)-\>Suspension Fasted Polymer (Moderate Particle Size)-\>Suspension Fed Polymer (Small Particle Size)
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
26-35 Years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
3 Participants
|
2 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
18 Participants
n=4 Participants
|
|
Age, Customized
36-45 Years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
14 Participants
n=4 Participants
|
|
Age, Customized
>45 Years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
14 Participants
n=4 Participants
|
|
Age, Customized
<18 Years
|
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
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
|
Age, Customized
18-25 Years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
2 Participants
|
2 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
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
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
7 Participants
n=114 Participants
|
6 Participants
|
6 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
61 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
5 Participants
|
6 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
54 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
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
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
1 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
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
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
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
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
6 Participants
|
5 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
52 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2)Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention were included in safety analysis set. Participants were analyzed according to the product they actually received.
Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Treatment-related TEAEs were any untoward medical occurrence attributed to study intervention. Relatedness to study treatment was determined by the investigator. Duration of participation of Part 1 and Part 3, from the screening visit to the follow-up phone call, was approximately 15 weeks. Duration of participation of Part 2, from the screening visit to the follow-up phone call, was approximately 10 weeks.
Outcome measures
| Measure |
Part 2: PF-07059013 1600 mg MD With Polymer
n=7 Participants
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 3000 mg MD With Polymer
n=6 Participants
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 4000 mg MD With Polymer
n=6 Participants
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 1: Placebo Single Dose (SD) With Polymer
n=18 Participants
In Part 1, participants were given a single dose of study intervention assigned. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 1: PF-07059013 100 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 250 mg SD With Polymer
n=5 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 500 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 1000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 2000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF- 07059013 2000 mg SD Without Polymer
n=9 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD Without Polymer
n=8 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 2: Placebo Multiple Doses (MD) With Polymer
n=8 Participants
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 2: PF-07059013 800 mg MD With Polymer
n=8 Participants
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 3: Suspension Fasted Polymer (Small Particle Size)
n=3 Participants
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 3: Tablet Fasted Without Polymer
n=4 Participants
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions.
|
Part 3: Suspension Fed Polymer (Small Particle Size)
n=1 Participants
In Part 3, participants were given a single dose of study intervention assigned under fed conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE)
All-causality
|
7 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE)
Treatment-related
|
6 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part 1: from Screening to Day 8; Part 2: from Screening to Day 21; Part 3: from Screening to Day 5.Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention were included in safety analysis set. Participants were analyzed according to the product they actually received.
Protocol-required safety laboratory assessments included chemistry, hematology, and urinalysis (and microscopy, if needed). Each parameter was evaluated against commonly used and widely accepted criteria. Laboratory test with abnormalities are reported. Evaluation activities as: Part 1: At Screening, Day -1, and Day 1 (at 8 hours post dose), 2, 5, 8. Part 2: At Screening, Day -1, 1, 2, 4, 7, 10, 14, 18, 21. Part 3: At Screening, Day -1, 2, 5.
Outcome measures
| Measure |
Part 2: PF-07059013 1600 mg MD With Polymer
n=7 Participants
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 3000 mg MD With Polymer
n=6 Participants
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 4000 mg MD With Polymer
n=6 Participants
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 1: Placebo Single Dose (SD) With Polymer
n=18 Participants
In Part 1, participants were given a single dose of study intervention assigned. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 1: PF-07059013 100 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 250 mg SD With Polymer
n=5 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 500 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 1000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 2000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF- 07059013 2000 mg SD Without Polymer
n=9 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD Without Polymer
n=8 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 2: Placebo Multiple Doses (MD) With Polymer
n=8 Participants
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 2: PF-07059013 800 mg MD With Polymer
n=8 Participants
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 3: Suspension Fasted Polymer (Small Particle Size)
n=3 Participants
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 3: Tablet Fasted Without Polymer
n=4 Participants
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions.
|
Part 3: Suspension Fed Polymer (Small Particle Size)
n=1 Participants
In Part 3, participants were given a single dose of study intervention assigned under fed conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Findings of Potential Clinical Importance
Neutrophils/Leukocytes (%) <0.8 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Findings of Potential Clinical Importance
URINE Bilirubin >=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Findings of Potential Clinical Importance
Leukocyte Esterase (Urinalysis) >=1
|
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
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Findings of Potential Clinical Importance
URINE Protein >=1
|
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
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Findings of Potential Clinical Importance
URINE Hemoglobin >=1
|
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
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Findings of Potential Clinical Importance
Specific Gravity (Urinalysis) <1.003
|
0 Participants
|
1 Participants
|
1 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 Laboratory Test Findings of Potential Clinical Importance
Reticulocytes (10^9/L) >1.5 x upper limit of normal (ULN)
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Findings of Potential Clinical Importance
Reticulocytes/Erythrocytes (L/L) >1.5 x ULN
|
0 Participants
|
1 Participants
|
2 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 Laboratory Test Findings of Potential Clinical Importance
Lymphocytes/Leukocytes (%) <0.8 x lower limit of normal (LLN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Findings of Potential Clinical Importance
Neutrophils(10^9/L) <0.8 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Findings of Potential Clinical Importance
Eosinophils (10^9/L) >1.2 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Findings of Potential Clinical Importance
Eosinophils/Leukocytes (%) >1.2 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Findings of Potential Clinical Importance
Monocytes(10^9/L) >1.2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Findings of Potential Clinical Importance
Monocytes/Leukocytes (%) >1.2 x ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Findings of Potential Clinical Importance
Erythropoietin (IU/L) >1.0 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Findings of Potential Clinical Importance
Direct Bilirubin (micromol/L) >1.5 x ULN
|
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
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Findings of Potential Clinical Importance
Urea Nitrogen (mmol/L) >1.3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Findings of Potential Clinical Importance
Urea (mmol/L) >1.3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Findings of Potential Clinical Importance
Lactic Acid (mmol/L) >1.0 x ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part 1: from Screening to Day 8; Part 2: from Screening to Day 21; Part 3: from Screening to Day 5.Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention were included in safety analysis set. Participants were analyzed according to the product they actually received.
Vital sign data included supine blood pressure, pulse rate, orthostatic blood pressure and oral temperature. Vital signs with abnormalities are reported. Evaluation activities as: Part 1: Supine blood pressure and pulse rate: At Screening, 0, 0.5, 1, 2, 5, 8, 12, 24, 36, 48, 72, 96, and 168 hours post dose. Orthostatic blood pressure, respiratory rate and oral temperature: 0, 2, 8, and 24 hours post dose. Part 2: Supine blood pressure and pulse rate: At Screening, Day 1, 2, 4, 7, 10, 14, 15, 18, 21. Orthostatic blood pressure, respiratory rate and oral temperature: Day 1, 7, 14, 18. Part 3: Supine blood pressure and pulse rate: At Screening, 0, 2, 5, 8, 12, 24, 48, and 96 hours post dose. Respiratory rate and oral temperature: 0, 24 and 96 hours post dose.
Outcome measures
| Measure |
Part 2: PF-07059013 1600 mg MD With Polymer
n=7 Participants
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 3000 mg MD With Polymer
n=6 Participants
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 4000 mg MD With Polymer
n=6 Participants
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 1: Placebo Single Dose (SD) With Polymer
n=18 Participants
In Part 1, participants were given a single dose of study intervention assigned. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 1: PF-07059013 100 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 250 mg SD With Polymer
n=5 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 500 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 1000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 2000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF- 07059013 2000 mg SD Without Polymer
n=9 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD Without Polymer
n=8 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 2: Placebo Multiple Doses (MD) With Polymer
n=8 Participants
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 2: PF-07059013 800 mg MD With Polymer
n=8 Participants
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 3: Suspension Fasted Polymer (Small Particle Size)
n=3 Participants
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 3: Tablet Fasted Without Polymer
n=4 Participants
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions.
|
Part 3: Suspension Fed Polymer (Small Particle Size)
n=1 Participants
In Part 3, participants were given a single dose of study intervention assigned under fed conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs Findings of Potential Clinical Importance
Supine Diastolic Blood Pressure (mmHg) Value <50
|
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 Vital Signs Findings of Potential Clinical Importance
Supine Pulse Rate (beats/min) Value >120 bpm
|
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 Vital Signs Findings of Potential Clinical Importance
Supine Systolic Blood Pressure (mmHg) Value <90
|
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 Vital Signs Findings of Potential Clinical Importance
Supine Systolic Blood Pressure (mmHg) Change >=30 increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Findings of Potential Clinical Importance
Supine Systolic Blood Pressure (mmHg) Change >=30 decrease
|
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 Vital Signs Findings of Potential Clinical Importance
Supine Diastolic Blood Pressure (mmHg) Change >=20 increase
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Findings of Potential Clinical Importance
Supine Diastolic Blood Pressure (mmHg) Change >=20 decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 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 Vital Signs Findings of Potential Clinical Importance
Supine Pulse Rate (beats/min) Value <40 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
1 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
|
PRIMARY outcome
Timeframe: Part 1: from Screening to Day 8; Part 2: from Screening to Day 21; Part 3: from Screening to Day 5.Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention were included in safety analysis set. Participants were analyzed according to the product they actually received.
Clinical significance of 12-Lead ECG data was assessed by the investigator. ECG findings with abnormalities were reported. Evaluation activities as: Part 1: At Screening, 0, 0.5, 1, 2, 5, 8, 12, 24, 36, 48, 72, 96, and 168 hours post dose. Part 2: At Screening, Day 1, 2, 4, 7, 10, 14, 15, 18, 21. Part 3: At Screening, 0, 2, 5, 8, 12, 24, 48, and 96 hours post dose.
Outcome measures
| Measure |
Part 2: PF-07059013 1600 mg MD With Polymer
n=7 Participants
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 3000 mg MD With Polymer
n=6 Participants
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 4000 mg MD With Polymer
n=6 Participants
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 1: Placebo Single Dose (SD) With Polymer
n=18 Participants
In Part 1, participants were given a single dose of study intervention assigned. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 1: PF-07059013 100 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 250 mg SD With Polymer
n=5 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 500 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 1000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 2000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF- 07059013 2000 mg SD Without Polymer
n=9 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD Without Polymer
n=8 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 2: Placebo Multiple Doses (MD) With Polymer
n=8 Participants
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 2: PF-07059013 800 mg MD With Polymer
n=8 Participants
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 3: Suspension Fasted Polymer (Small Particle Size)
n=3 Participants
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 3: Tablet Fasted Without Polymer
n=4 Participants
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions.
|
Part 3: Suspension Fed Polymer (Small Particle Size)
n=1 Participants
In Part 3, participants were given a single dose of study intervention assigned under fed conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance
QTCF interval, Aggregate (msec), 30<=Change<=60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance
PR Interval, Aggregate (msec) %Change>=25/50
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance
QTCB Interval, Aggregate (msec), 450<Value<480
|
0 Participants
|
0 Participants
|
0 Participants
|
1 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 Electrocardiogram (ECG) Findings of Potential Clinical Importance
QTCB Interval, Aggregate (msec), 30<=Change<=60
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 5, 8, 12, 24, 36, 48, 72 (period 2-4 only), 96 (period 2-4 only), and 168 hours post dose of each period.Population: The analysis population referred to all participants dosed who had at least 1 of the pharmacokinetics (PK) parameters of secondary interest.
PF-07059013 Blood and Plasma Cmax for Part 1 was evaluated. For Part 1, in period 1, participants were given PF-07059013 100 mg SD and PF-07059013 250 mg SD, all with polymer; in period 2, participants were given PF-07059013 500 mg SD and PF-07059013 1000 mg SD, all with polymer; in period 3, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all with polymer; in period 4, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all without polymer.
Outcome measures
| Measure |
Part 2: PF-07059013 1600 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 3000 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 4000 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 1: Placebo Single Dose (SD) With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 1: PF-07059013 100 mg SD With Polymer
n=5 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 250 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 500 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 1000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 2000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD With Polymer
n=9 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF- 07059013 2000 mg SD Without Polymer
n=8 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD Without Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 2: Placebo Multiple Doses (MD) With Polymer
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 2: PF-07059013 800 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 3: Suspension Fasted Polymer (Small Particle Size)
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 3: Tablet Fasted Without Polymer
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions.
|
Part 3: Suspension Fed Polymer (Small Particle Size)
In Part 3, participants were given a single dose of study intervention assigned under fed conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-07059013 Blood and Plasma Maximum Observed Concentration (Cmax) of Part 1
Blood
|
—
|
—
|
—
|
4773 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 36
|
11990 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 43
|
25140 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 51
|
52830 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 38
|
104200 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 63
|
231700 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 31
|
107000 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 54
|
191700 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 55
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-07059013 Blood and Plasma Maximum Observed Concentration (Cmax) of Part 1
Plasma
|
—
|
—
|
—
|
88.51 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 19
|
160.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 31
|
250.1 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
509.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 22
|
555.3 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 30
|
917.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 38
|
496.1 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
796.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 39
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 5, 8, 12, 24, 36, 48, 72 (period 2-4 only), 96 (period 2-4 only), and 168 hours post dose of each period.Population: The analysis population referred to all participants dosed who had at least 1 of the PK parameters of secondary interest.
PF-07059013 Blood and Plasma Tmax for Part 1 was evaluated. For Part 1, in period 1, participants were given PF-07059013 100 mg SD and PF-07059013 250 mg SD, all with polymer; in period 2, participants were given PF-07059013 500 mg SD and PF-07059013 1000 mg SD, all with polymer; in period 3, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all with polymer; in period 4, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all without polymer.
Outcome measures
| Measure |
Part 2: PF-07059013 1600 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 3000 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 4000 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 1: Placebo Single Dose (SD) With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 1: PF-07059013 100 mg SD With Polymer
n=5 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 250 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 500 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 1000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 2000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD With Polymer
n=9 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF- 07059013 2000 mg SD Without Polymer
n=8 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD Without Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 2: Placebo Multiple Doses (MD) With Polymer
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 2: PF-07059013 800 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 3: Suspension Fasted Polymer (Small Particle Size)
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 3: Tablet Fasted Without Polymer
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions.
|
Part 3: Suspension Fed Polymer (Small Particle Size)
In Part 3, participants were given a single dose of study intervention assigned under fed conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-07059013 Blood and Plasma Time for Cmax (Tmax) of Part 1
Plasma
|
—
|
—
|
—
|
1.00 hour
Interval 0.517 to 2.02
|
1.00 hour
Interval 0.5 to 2.0
|
2.00 hour
Interval 0.6 to 2.0
|
2.00 hour
Interval 1.0 to 8.0
|
2.00 hour
Interval 2.0 to 2.12
|
3.57 hour
Interval 2.0 to 5.0
|
2.03 hour
Interval 1.0 to 5.0
|
2.01 hour
Interval 2.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-07059013 Blood and Plasma Time for Cmax (Tmax) of Part 1
Blood
|
—
|
—
|
—
|
1.00 hour
Interval 0.5 to 1.0
|
1.00 hour
Interval 0.5 to 1.0
|
1.00 hour
Interval 1.0 to 2.0
|
2.00 hour
Interval 1.0 to 2.07
|
2.00 hour
Interval 2.0 to 5.0
|
5.00 hour
Interval 2.0 to 5.0
|
2.03 hour
Interval 2.0 to 5.0
|
2.00 hour
Interval 2.0 to 5.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 5, 8, 12, 24, 36, 48, 72 (period 2-4 only), 96 (period 2-4 only), and 168 hours post dose of each period.Population: The analysis population referred to all participants dosed who had at least 1 of the PK parameters of secondary interest.
PF-07059013 Blood and Plasma AUClast of Part 1 was evaluated. For Part 1, in period 1, participants were given PF-07059013 100 mg SD and PF-07059013 250 mg SD, all with polymer; in period 2, participants were given PF-07059013 500 mg SD and PF-07059013 1000 mg SD, all with polymer; in period 3, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all with polymer; in period 4, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all without polymer.
Outcome measures
| Measure |
Part 2: PF-07059013 1600 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 3000 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 4000 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 1: Placebo Single Dose (SD) With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 1: PF-07059013 100 mg SD With Polymer
n=5 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 250 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 500 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 1000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 2000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD With Polymer
n=9 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF- 07059013 2000 mg SD Without Polymer
n=8 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD Without Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 2: Placebo Multiple Doses (MD) With Polymer
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 2: PF-07059013 800 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 3: Suspension Fasted Polymer (Small Particle Size)
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 3: Tablet Fasted Without Polymer
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions.
|
Part 3: Suspension Fed Polymer (Small Particle Size)
In Part 3, participants were given a single dose of study intervention assigned under fed conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Part 1
Blood
|
—
|
—
|
—
|
14870 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 49
|
73300 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 45
|
211400 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 65
|
639800 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 47
|
1582000 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 68
|
4091000 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 34
|
1692000 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 69
|
3562000 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 77
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Part 1
Plasma
|
—
|
—
|
—
|
520.5 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 45
|
1699 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 28
|
3224 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 37
|
7505 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 24
|
12310 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 16
|
20520 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 26
|
12640 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 30
|
19130 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 56
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 4, 6, 8, 12 hours post dose on Day 1, 7, and 14.Population: The analysis population referred to all participants dosed who had at least 1 of the PK parameters of secondary interest.
PF-07059013 Blood and Plasma Cmax of Part 2 was evaluated.
Outcome measures
| Measure |
Part 2: PF-07059013 1600 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 3000 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 4000 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 1: Placebo Single Dose (SD) With Polymer
n=8 Participants
In Part 1, participants were given a single dose of study intervention assigned. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 1: PF-07059013 100 mg SD With Polymer
n=7 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 250 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 500 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 1000 mg SD With Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 2000 mg SD With Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD With Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF- 07059013 2000 mg SD Without Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD Without Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 2: Placebo Multiple Doses (MD) With Polymer
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 2: PF-07059013 800 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 3: Suspension Fasted Polymer (Small Particle Size)
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 3: Tablet Fasted Without Polymer
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions.
|
Part 3: Suspension Fed Polymer (Small Particle Size)
In Part 3, participants were given a single dose of study intervention assigned under fed conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-07059013 Blood and Plasma Cmax of Part 2
Day 14 in Blood
|
—
|
—
|
—
|
79690 ng/mL
Geometric Coefficient of Variation 21
|
275800 ng/mL
Geometric Coefficient of Variation 28
|
520000 ng/mL
Geometric Coefficient of Variation 20
|
623700 ng/mL
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-07059013 Blood and Plasma Cmax of Part 2
Day 1 in Blood
|
—
|
—
|
—
|
57230 ng/mL
Geometric Coefficient of Variation 20
|
149500 ng/mL
Geometric Coefficient of Variation 29
|
332100 ng/mL
Geometric Coefficient of Variation 27
|
337500 ng/mL
Geometric Coefficient of Variation 37
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-07059013 Blood and Plasma Cmax of Part 2
Day 1 in Plasma
|
—
|
—
|
—
|
427.1 ng/mL
Geometric Coefficient of Variation 23
|
597.2 ng/mL
Geometric Coefficient of Variation 24
|
1071 ng/mL
Geometric Coefficient of Variation 21
|
1339 ng/mL
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-07059013 Blood and Plasma Cmax of Part 2
Day 7 in Blood
|
—
|
—
|
—
|
86020 ng/mL
Geometric Coefficient of Variation 18
|
275700 ng/mL
Geometric Coefficient of Variation 28
|
521600 ng/mL
Geometric Coefficient of Variation 38
|
576900 ng/mL
Geometric Coefficient of Variation 17
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-07059013 Blood and Plasma Cmax of Part 2
Day 7 in Plasma
|
—
|
—
|
—
|
513.6 ng/mL
Geometric Coefficient of Variation 22
|
913.9 ng/mL
Geometric Coefficient of Variation 40
|
1496 ng/mL
Geometric Coefficient of Variation 23
|
2157 ng/mL
Geometric Coefficient of Variation 32
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-07059013 Blood and Plasma Cmax of Part 2
Day 14 in Plasma
|
—
|
—
|
—
|
569.4 ng/mL
Geometric Coefficient of Variation 44
|
868.2 ng/mL
Geometric Coefficient of Variation 33
|
1791 ng/mL
Geometric Coefficient of Variation 33
|
1958 ng/mL
Geometric Coefficient of Variation 18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 4, 6, 8, 12 hours post dose on Day 1, 7, and 14.Population: The analysis population referred to all participants dosed who had at least 1 of the PK parameters of secondary interest.
PF-07059013 Blood and Plasma Tmax of Part 2 was evaluated.
Outcome measures
| Measure |
Part 2: PF-07059013 1600 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 3000 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 4000 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 1: Placebo Single Dose (SD) With Polymer
n=8 Participants
In Part 1, participants were given a single dose of study intervention assigned. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 1: PF-07059013 100 mg SD With Polymer
n=7 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 250 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 500 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 1000 mg SD With Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 2000 mg SD With Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD With Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF- 07059013 2000 mg SD Without Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD Without Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 2: Placebo Multiple Doses (MD) With Polymer
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 2: PF-07059013 800 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 3: Suspension Fasted Polymer (Small Particle Size)
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 3: Tablet Fasted Without Polymer
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions.
|
Part 3: Suspension Fed Polymer (Small Particle Size)
In Part 3, participants were given a single dose of study intervention assigned under fed conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-07059013 Blood and Plasma Tmax of Part 2
Day 1 in Blood
|
—
|
—
|
—
|
3.01 hour
Interval 2.0 to 4.08
|
4.00 hour
Interval 2.0 to 4.02
|
4.07 hour
Interval 4.03 to 6.0
|
4.02 hour
Interval 4.0 to 6.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-07059013 Blood and Plasma Tmax of Part 2
Day 1 in Plasma
|
—
|
—
|
—
|
3.02 hour
Interval 1.0 to 4.08
|
4.00 hour
Interval 4.0 to 8.0
|
4.05 hour
Interval 4.0 to 8.1
|
6.00 hour
Interval 2.03 to 6.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-07059013 Blood and Plasma Tmax of Part 2
Day 7 in Blood
|
—
|
—
|
—
|
2.03 hour
Interval 2.0 to 4.0
|
4.03 hour
Interval 4.0 to 4.1
|
4.02 hour
Interval 2.0 to 4.12
|
4.03 hour
Interval 2.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-07059013 Blood and Plasma Tmax of Part 2
Day 7 in Plasma
|
—
|
—
|
—
|
4.00 hour
Interval 2.0 to 12.0
|
4.07 hour
Interval 4.02 to 8.02
|
4.05 hour
Interval 2.0 to 8.0
|
5.01 hour
Interval 4.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-07059013 Blood and Plasma Tmax of Part 2
Day 14 in Blood
|
—
|
—
|
—
|
2.02 hour
Interval 1.0 to 12.0
|
4.00 hour
Interval 2.0 to 4.02
|
4.01 hour
Interval 2.02 to 6.0
|
4.03 hour
Interval 2.0 to 6.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-07059013 Blood and Plasma Tmax of Part 2
Day 14 in Plasma
|
—
|
—
|
—
|
2.01 hour
Interval 2.0 to 6.02
|
4.02 hour
Interval 2.0 to 8.0
|
4.01 hour
Interval 2.0 to 8.02
|
4.03 hour
Interval 2.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 4, 6, 8, 12 hours post dose on Day 1, 7, and 14.Population: The analysis population referred to all participants dosed who had at least 1 of the PK parameters of secondary interest.
PF-07059013 Blood and Plasma AUCtau (the Dosing Interval, Where Tau = 24 Hours for QD Dosing) for Part 2 was evaluated.
Outcome measures
| Measure |
Part 2: PF-07059013 1600 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 3000 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 4000 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 1: Placebo Single Dose (SD) With Polymer
n=8 Participants
In Part 1, participants were given a single dose of study intervention assigned. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 1: PF-07059013 100 mg SD With Polymer
n=7 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 250 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 500 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 1000 mg SD With Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 2000 mg SD With Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD With Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF- 07059013 2000 mg SD Without Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD Without Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 2: Placebo Multiple Doses (MD) With Polymer
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 2: PF-07059013 800 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 3: Suspension Fasted Polymer (Small Particle Size)
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 3: Tablet Fasted Without Polymer
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions.
|
Part 3: Suspension Fed Polymer (Small Particle Size)
In Part 3, participants were given a single dose of study intervention assigned under fed conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2
Day 1 in Blood
|
—
|
—
|
—
|
594600 ng*hr/mL
Geometric Coefficient of Variation 22
|
1942000 ng*hr/mL
Geometric Coefficient of Variation 37
|
4408000 ng*hr/mL
Geometric Coefficient of Variation 33
|
4884000 ng*hr/mL
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2
Day 1 in Plasma
|
—
|
—
|
—
|
5024 ng*hr/mL
Geometric Coefficient of Variation 15
|
8358 ng*hr/mL
Geometric Coefficient of Variation 24
|
16210 ng*hr/mL
Geometric Coefficient of Variation 18
|
18670 ng*hr/mL
Geometric Coefficient of Variation 37
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2
Day 7 in Blood
|
—
|
—
|
—
|
1184000 ng*hr/mL
Geometric Coefficient of Variation 31
|
4108000 ng*hr/mL
Geometric Coefficient of Variation 42
|
8027000 ng*hr/mL
Geometric Coefficient of Variation 38
|
8666000 ng*hr/mL
Geometric Coefficient of Variation 18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2
Day 7 in Plasma
|
—
|
—
|
—
|
7608 ng*hr/mL
Geometric Coefficient of Variation 25
|
13680 ng*hr/mL
Geometric Coefficient of Variation 38
|
24280 ng*hr/mL
Geometric Coefficient of Variation 21
|
29960 ng*hr/mL
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2
Day 14 in Blood
|
—
|
—
|
—
|
981000 ng*hr/mL
Geometric Coefficient of Variation 29
|
4165000 ng*hr/mL
Geometric Coefficient of Variation 29
|
7730000 ng*hr/mL
Geometric Coefficient of Variation 21
|
9944000 ng*hr/mL
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2
Day 14 in Plasma
|
—
|
—
|
—
|
7568 ng*hr/mL
Geometric Coefficient of Variation 26
|
14330 ng*hr/mL
Geometric Coefficient of Variation 22
|
26500 ng*hr/mL
Geometric Coefficient of Variation 20
|
31640 ng*hr/mL
Geometric Coefficient of Variation 25
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: 0 and 8 hours post dose.Population: The analysis population referred to all participants dosed who had at least 1 of the pharmacodynamics parameters of secondary interest.
p20 and p50 change from baseline in Part 1 was evaluated.
Outcome measures
| Measure |
Part 2: PF-07059013 1600 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 3000 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 4000 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 1: Placebo Single Dose (SD) With Polymer
n=18 Participants
In Part 1, participants were given a single dose of study intervention assigned. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 1: PF-07059013 100 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 250 mg SD With Polymer
n=5 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 500 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 1000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 2000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF- 07059013 2000 mg SD Without Polymer
n=9 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD Without Polymer
n=8 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 2: Placebo Multiple Doses (MD) With Polymer
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 2: PF-07059013 800 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 3: Suspension Fasted Polymer (Small Particle Size)
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 3: Tablet Fasted Without Polymer
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions.
|
Part 3: Suspension Fed Polymer (Small Particle Size)
In Part 3, participants were given a single dose of study intervention assigned under fed conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1
p20 at Day 1 8H
|
—
|
—
|
—
|
0.05 mmHg
Interval -0.3 to 1.3
|
0.10 mmHg
Interval -0.1 to 1.0
|
0.00 mmHg
Interval -0.2 to 1.9
|
-0.05 mmHg
Interval -0.7 to 0.4
|
-0.05 mmHg
Interval -1.1 to 0.3
|
-0.40 mmHg
Interval -1.0 to -0.2
|
-1.00 mmHg
Interval -2.0 to -0.4
|
-0.70 mmHg
Interval -1.1 to -0.1
|
-1.30 mmHg
Interval -1.6 to -0.2
|
—
|
—
|
—
|
—
|
—
|
|
p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1
p50 at Day 1 8H
|
—
|
—
|
—
|
0.50 mmHg
Interval -0.1 to 3.3
|
0.25 mmHg
Interval -0.2 to 1.6
|
0.20 mmHg
Interval -0.2 to 1.6
|
0.15 mmHg
Interval -0.9 to 1.1
|
0.50 mmHg
Interval -1.1 to 0.9
|
-0.25 mmHg
Interval -0.7 to 0.1
|
-0.45 mmHg
Interval -1.2 to 0.1
|
-0.30 mmHg
Interval -0.9 to 0.8
|
-0.45 mmHg
Interval -1.6 to 0.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 2: 0 and 8 hours post dose on Day 1, 7 and 14, and on Day 2, 15, 18.Population: The analysis population referred to all participants dosed who had at least 1 of the pharmacodynamics parameters of secondary interest.
p20 and p50 change from baseline in Part 2 was evaluated.
Outcome measures
| Measure |
Part 2: PF-07059013 1600 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 3000 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 4000 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 1: Placebo Single Dose (SD) With Polymer
n=8 Participants
In Part 1, participants were given a single dose of study intervention assigned. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 1: PF-07059013 100 mg SD With Polymer
n=8 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 250 mg SD With Polymer
n=7 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 500 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 1000 mg SD With Polymer
n=6 Participants
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 2000 mg SD With Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD With Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF- 07059013 2000 mg SD Without Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD Without Polymer
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 2: Placebo Multiple Doses (MD) With Polymer
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 2: PF-07059013 800 mg MD With Polymer
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 3: Suspension Fasted Polymer (Small Particle Size)
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 3: Tablet Fasted Without Polymer
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions.
|
Part 3: Suspension Fed Polymer (Small Particle Size)
In Part 3, participants were given a single dose of study intervention assigned under fed conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2
p50 at Day 1 2H
|
—
|
—
|
—
|
0.30 mmHg
Interval -0.7 to 1.1
|
0.00 mmHg
Interval -0.4 to 1.2
|
-0.40 mmHg
Interval -0.8 to 0.1
|
-0.35 mmHg
Interval -1.3 to 0.0
|
-0.95 mmHg
Interval -2.2 to 0.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2
p20 at Day 14 0H
|
—
|
—
|
—
|
0.35 mmHg
Interval -1.2 to 1.9
|
0.40 mmHg
Interval -2.1 to 0.8
|
0.00 mmHg
Interval -0.6 to 2.4
|
-2.70 mmHg
Interval -4.1 to -0.1
|
-2.20 mmHg
Interval -4.1 to 1.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2
p20 at Day 14 2H
|
—
|
—
|
—
|
0.40 mmHg
Interval -1.0 to 2.2
|
-0.05 mmHg
Interval -2.3 to 0.6
|
-0.20 mmHg
Interval -1.3 to 1.8
|
-5.20 mmHg
Interval -11.1 to -0.4
|
-8.05 mmHg
Interval -12.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2
p20 at Day 14 24H
|
—
|
—
|
—
|
-0.65 mmHg
Interval -1.7 to 1.3
|
0.50 mmHg
Interval -2.1 to 1.5
|
0.20 mmHg
Interval -2.4 to 2.0
|
-1.40 mmHg
Interval -3.7 to 2.0
|
-1.35 mmHg
Interval -2.4 to 1.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2
p20 at Day 14 96H
|
—
|
—
|
—
|
-0.10 mmHg
Interval -1.6 to 0.2
|
—
|
1.70 mmHg
Interval -0.1 to 2.4
|
0.15 mmHg
Interval -0.7 to 0.8
|
1.40 mmHg
Interval 0.8 to 3.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2
p20 at Day 1 2H
|
—
|
—
|
—
|
0.10 mmHg
Interval -0.6 to 0.6
|
-0.30 mmHg
Interval -1.4 to 0.2
|
-0.90 mmHg
Interval -1.1 to -0.4
|
-1.25 mmHg
Interval -2.9 to -0.4
|
-2.00 mmHg
Interval -3.8 to -0.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2
p20 at Day 2
|
—
|
—
|
—
|
0.30 mmHg
Interval -1.5 to 1.5
|
0.55 mmHg
Interval -2.1 to 0.8
|
-1.00 mmHg
Interval -1.6 to 0.1
|
-0.45 mmHg
Interval -1.2 to 0.9
|
-2.10 mmHg
Interval -2.4 to -1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2
p20 at Day 7 0H
|
—
|
—
|
—
|
0.70 mmHg
Interval -1.7 to 1.0
|
-0.65 mmHg
Interval -2.6 to 0.2
|
0.00 mmHg
Interval -0.3 to 0.8
|
-1.60 mmHg
Interval -3.0 to 2.4
|
-1.05 mmHg
Interval -2.3 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2
p20 at Day 7 2H
|
—
|
—
|
—
|
0.30 mmHg
Interval -1.5 to 1.3
|
-1.20 mmHg
Interval -2.9 to -0.4
|
-0.70 mmHg
Interval -1.2 to -0.1
|
-3.60 mmHg
Interval -6.6 to 1.0
|
-3.05 mmHg
Interval -9.4 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2
p50 at Day 2
|
—
|
—
|
—
|
0.85 mmHg
Interval -2.0 to 2.3
|
1.00 mmHg
Interval -4.1 to 1.5
|
-0.40 mmHg
Interval -1.0 to 0.6
|
0.25 mmHg
Interval -0.6 to 1.1
|
-1.45 mmHg
Interval -2.0 to -0.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2
p50 at Day 7 0H
|
—
|
—
|
—
|
0.60 mmHg
Interval -3.2 to 2.2
|
-1.30 mmHg
Interval -5.6 to 1.4
|
0.70 mmHg
Interval 0.1 to 1.8
|
-0.30 mmHg
Interval -1.9 to 4.7
|
0.10 mmHg
Interval -0.8 to 1.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2
p50 at Day 7 2H
|
—
|
—
|
—
|
0.80 mmHg
Interval -2.8 to 2.4
|
-1.30 mmHg
Interval -5.4 to 1.0
|
0.70 mmHg
Interval -0.3 to 1.6
|
-2.20 mmHg
Interval -2.6 to 2.9
|
-0.60 mmHg
Interval -4.3 to 0.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2
p50 at Day 14 0H
|
—
|
—
|
—
|
0.60 mmHg
Interval -1.9 to 1.7
|
0.70 mmHg
Interval -4.3 to 1.6
|
1.40 mmHg
Interval -0.3 to 4.1
|
-2.00 mmHg
Interval -3.3 to -0.1
|
-0.70 mmHg
Interval -2.1 to 1.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2
p50 at Day 14 2H
|
—
|
—
|
—
|
0.75 mmHg
Interval -1.1 to 2.2
|
1.05 mmHg
Interval -4.3 to 2.2
|
1.00 mmHg
Interval -0.6 to 3.6
|
-3.50 mmHg
Interval -6.3 to -0.2
|
-2.80 mmHg
Interval -6.9 to 0.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2
p50 at Day 14 24H
|
—
|
—
|
—
|
-0.85 mmHg
Interval -2.2 to 2.3
|
1.30 mmHg
Interval -4.0 to 2.7
|
1.10 mmHg
Interval -2.3 to 3.5
|
-0.50 mmHg
Interval -3.2 to 3.5
|
0.45 mmHg
Interval -0.9 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2
p50 at Day 14 96H
|
—
|
—
|
—
|
-0.70 mmHg
Interval -2.7 to 0.9
|
—
|
2.70 mmHg
Interval 1.0 to 3.2
|
0.15 mmHg
Interval -0.4 to 1.4
|
2.90 mmHg
Interval 2.1 to 4.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1: Placebo Single Dose (SD) With Polymer
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: PF-07059013 100 mg SD With Polymer
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: PF-07059013 250 mg SD With Polymer
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: PF-07059013 500 mg SD With Polymer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1: PF-07059013 1000 mg SD With Polymer
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1: PF-07059013 2000 mg SD With Polymer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1: PF-07059013 3000 mg SD With Polymer
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1: PF- 07059013 2000 mg SD Without Polymer
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: PF-07059013 3000 mg SD Without Polymer
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2: Placebo Multiple Doses (MD) With Polymer
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2: PF-07059013 800 mg MD With Polymer
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 2: PF-07059013 1600 mg MD With Polymer
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 2: PF-07059013 3000 mg MD With Polymer
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2: PF-07059013 4000 mg MD With Polymer
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 3: Suspension Fasted Polymer (Small Particle Size)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 3: Tablet Fasted Without Polymer
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 3: Suspension Fed Polymer (Small Particle Size)
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 |
Part 1: Placebo Single Dose (SD) With Polymer
n=18 participants at risk
In Part 1, participants were given a single dose of study intervention assigned. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 1: PF-07059013 100 mg SD With Polymer
n=6 participants at risk
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 250 mg SD With Polymer
n=5 participants at risk
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 500 mg SD With Polymer
n=6 participants at risk
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 1000 mg SD With Polymer
n=6 participants at risk
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 2000 mg SD With Polymer
n=6 participants at risk
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD With Polymer
n=6 participants at risk
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF- 07059013 2000 mg SD Without Polymer
n=9 participants at risk
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 1: PF-07059013 3000 mg SD Without Polymer
n=8 participants at risk
In Part 1, participants were given a single dose of study intervention assigned.
|
Part 2: Placebo Multiple Doses (MD) With Polymer
n=8 participants at risk
In Part 2, participants were given multiple doses of study intervention once daily (QD) for 14 days. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 2: PF-07059013 800 mg MD With Polymer
n=8 participants at risk
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 1600 mg MD With Polymer
n=7 participants at risk
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 3000 mg MD With Polymer
n=6 participants at risk
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 2: PF-07059013 4000 mg MD With Polymer
n=6 participants at risk
In Part 2, participants were given multiple doses of study intervention QD for 14 days.
|
Part 3: Suspension Fasted Polymer (Small Particle Size)
n=3 participants at risk
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions. The presence/absence of polymer is utilized to select the preferred formulation composition.
|
Part 3: Tablet Fasted Without Polymer
n=4 participants at risk
In Part 3, participants were given a single dose of study intervention assigned under fasted conditions.
|
Part 3: Suspension Fed Polymer (Small Particle Size)
n=1 participants at risk
In Part 3, participants were given a single dose of study intervention assigned under fed conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
14.3%
1/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Gastrointestinal disorders
Anal Haemorrhage
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
14.3%
1/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Gastrointestinal disorders
Faeces Discoloured
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
14.3%
1/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
General disorders
Chest Discomfort
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
General disorders
Chest Pain
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
General disorders
Fatigue
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
25.0%
2/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
14.3%
1/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
General disorders
Pyrexia
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
14.3%
1/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Injury, poisoning and procedural complications
Burn Oesophageal
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
28.6%
2/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Nervous system disorders
Dizziness Postural
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Musculoskeletal and connective tissue disorders
Limb Discomfort
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Nervous system disorders
Head Discomfort
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
14.3%
1/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
14.3%
1/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
14.3%
1/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Vascular disorders
Haematoma
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
33.3%
1/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Vascular disorders
Hot Flush
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
14.3%
1/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Gastrointestinal disorders
Tongue Haematoma
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
25.0%
1/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
33.3%
1/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
33.3%
1/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
14.3%
1/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
33.3%
1/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
28.6%
2/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
25.0%
1/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
11.1%
1/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
25.0%
2/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
50.0%
2/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
33.3%
1/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
25.0%
1/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
14.3%
1/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
33.3%
1/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
14.3%
1/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
33.3%
2/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
25.0%
1/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
33.3%
1/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
General disorders
Application Site Pruritus
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
11.1%
1/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
General disorders
Puncture Site Pain
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Infections and infestations
COVID-19
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
5.6%
1/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Investigations
SARS-CoV-2 Test Positive
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
20.0%
1/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
14.3%
1/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
20.0%
1/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Nervous system disorders
Presyncope
|
5.6%
1/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Renal and urinary disorders
Nocturia
|
5.6%
1/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
11.1%
1/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
25.0%
2/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Eye disorders
Conjunctival Hyperaemia
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
25.0%
2/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
14.3%
1/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Eye disorders
Ocular Hyperaemia
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
14.3%
1/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Eye disorders
Photophobia
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/18 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/5 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/9 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
12.5%
1/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/8 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/7 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
16.7%
1/6 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/3 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/4 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
0.00%
0/1 • Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place