Trial Outcomes & Findings for Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin (NCT NCT01163851)
NCT ID: NCT01163851
Last Updated: 2018-03-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Results posted on
2018-03-01
Participant Flow
Participant milestones
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
Treated
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Overall Study
Site Closure
|
0
|
1
|
|
Overall Study
Enrolled but not treated
|
1
|
0
|
Baseline Characteristics
Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin
Baseline characteristics by cohort
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Population: Pharmacokinetic (PK) parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615
|
17950000 nanogram*hour per milliliter
Standard Deviation 2779600
|
933800 nanogram*hour per milliliter
Standard Deviation 376350
|
PRIMARY outcome
Timeframe: 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615
|
2.59 hour
Interval 1.0 to 12.1
|
4.00 hour
Interval 1.0 to 7.92
|
PRIMARY outcome
Timeframe: 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of PF-04950615
|
105000 nanogram per milliliter
Standard Deviation 16587
|
14030 nanogram per milliliter
Standard Deviation 1680
|
PRIMARY outcome
Timeframe: 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure for each group respectively.
Plasma decay half-life is the time measured for the plasma concentration of PF-04950615 to decrease by one half.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=11 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=7 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Plasma Decay Half-Life (t1/2) of PF-04950615
|
157.50 hour
Standard Deviation 33.22
|
61.00 hour
Standard Deviation 8.89
|
PRIMARY outcome
Timeframe: 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure for each group respectively.
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=11 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=7 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Systemic Clearance (CL) of PF-04950615
|
0.0185 liter per hour
Standard Deviation 0.0041
|
0.0392 liter per hour
Standard Deviation 0.0031
|
PRIMARY outcome
Timeframe: 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure for each group respectively.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=11 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=7 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Volume of Distribution at Steady State (Vss) of PF-04950615
|
4.248 liter
Standard Deviation 1.099
|
3.436 liter
Standard Deviation 0.583
|
PRIMARY outcome
Timeframe: 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure for each group respectively.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=11 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=7 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of PF-04950615
|
17960000 nanogram*hour per milliliter
Standard Deviation 2828500
|
1094000 nanogram*hour per milliliter
Standard Deviation 123640
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.
AUCtau was the AUC from time 0 to the end of the dosing interval, where the dosing interval was 12 hours.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Atorvastatin
|
71.73 nanogram*hour per milliliter
Standard Deviation 32.22
|
89.17 nanogram*hour per milliliter
Standard Deviation 33.25
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Atorvastatin
|
1.16 hour
Interval 0.5 to 3.0
|
1.00 hour
Interval 0.5 to 3.02
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Atorvastatin
|
15.79 nanogram per milliliter
Standard Deviation 8.81
|
20.68 nanogram per milliliter
Standard Deviation 10.58
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure for each group respectively.
Plasma decay half-life is the time measured for the plasma concentration of atorvastatin to decrease by one half.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=10 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=11 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Plasma Decay Half-Life (t1/2) of Atorvastatin
|
5.12 hour
Standard Deviation 1.38
|
5.09 hour
Standard Deviation 0.74
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Apparent Oral Clearance (CL/F) of Atorvastatin
|
557.50 liter per hour
Standard Deviation 238.33
|
448.70 liter per hour
Standard Deviation 196.91
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' is signifying those participants who were evaluable for this measure for each group respectively.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=10 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=11 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of Atorvastatin
|
3950 liter
Standard Deviation 1952.8
|
3353 liter
Standard Deviation 1960.8
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 5
|
-14.30 milligram per deciliter
Standard Deviation 17.79
|
-16.2 milligram per deciliter
Standard Deviation 11.56
|
|
Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 6
|
-28.50 milligram per deciliter
Standard Deviation 17.22
|
-34.00 milligram per deciliter
Standard Deviation 19.13
|
|
Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 7
|
-33.30 milligram per deciliter
Standard Deviation 22.42
|
-47.20 milligram per deciliter
Standard Deviation 20.66
|
|
Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 15
|
-52.40 milligram per deciliter
Standard Deviation 35.31
|
-25.90 milligram per deciliter
Standard Deviation 31.94
|
|
Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 22
|
-57.20 milligram per deciliter
Standard Deviation 30.71
|
2.10 milligram per deciliter
Standard Deviation 36.01
|
|
Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 29
|
-56.90 milligram per deciliter
Standard Deviation 35.21
|
9.40 milligram per deciliter
Standard Deviation 33.12
|
|
Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 36
|
-55.50 milligram per deciliter
Standard Deviation 23.64
|
3.40 milligram per deciliter
Standard Deviation 33.09
|
|
Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 43
|
-32.30 milligram per deciliter
Standard Deviation 15.64
|
8.80 milligram per deciliter
Standard Deviation 34.18
|
|
Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 50
|
-11.40 milligram per deciliter
Standard Deviation 13.27
|
4.10 milligram per deciliter
Standard Deviation 29.02
|
|
Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 57
|
-1.50 milligram per deciliter
Standard Deviation 22.25
|
10.90 milligram per deciliter
Standard Deviation 35.79
|
|
Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 64
|
6.20 milligram per deciliter
Standard Deviation 24.62
|
12.10 milligram per deciliter
Standard Deviation 33.42
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 5
|
-13.90 milligram per deciliter
Standard Deviation 19.48
|
-21.60 milligram per deciliter
Standard Deviation 15.04
|
|
Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 6
|
-33.30 milligram per deciliter
Standard Deviation 19.04
|
-38.30 milligram per deciliter
Standard Deviation 18.03
|
|
Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 7
|
-37.30 milligram per deciliter
Standard Deviation 25.72
|
-50.00 milligram per deciliter
Standard Deviation 20.50
|
|
Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 15
|
-58.00 milligram per deciliter
Standard Deviation 39.02
|
-24.30 milligram per deciliter
Standard Deviation 38.29
|
|
Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 22
|
-61.30 milligram per deciliter
Standard Deviation 34.91
|
7.50 milligram per deciliter
Standard Deviation 38.05
|
|
Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 29
|
-62.60 milligram per deciliter
Standard Deviation 32.81
|
8.40 milligram per deciliter
Standard Deviation 36.28
|
|
Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 36
|
-56.30 milligram per deciliter
Standard Deviation 28.61
|
5.30 milligram per deciliter
Standard Deviation 36.43
|
|
Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 43
|
-28.90 milligram per deciliter
Standard Deviation 19.61
|
9.80 milligram per deciliter
Standard Deviation 38.40
|
|
Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 50
|
-6.30 milligram per deciliter
Standard Deviation 18.51
|
4.80 milligram per deciliter
Standard Deviation 34.39
|
|
Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 57
|
9.30 milligram per deciliter
Standard Deviation 31.92
|
18.50 milligram per deciliter
Standard Deviation 34.69
|
|
Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 64
|
12.10 milligram per deciliter
Standard Deviation 23.00
|
15.10 milligram per deciliter
Standard Deviation 31.48
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 36
|
-60.00 milligram per deciliter
Standard Deviation 29.56
|
3.50 milligram per deciliter
Standard Deviation 41.05
|
|
Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 43
|
-35.00 milligram per deciliter
Standard Deviation 18.14
|
6.60 milligram per deciliter
Standard Deviation 38.85
|
|
Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 50
|
-9.00 milligram per deciliter
Standard Deviation 17.87
|
3.10 milligram per deciliter
Standard Deviation 37.89
|
|
Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 5
|
12.60 milligram per deciliter
Standard Deviation 21.90
|
-19.40 milligram per deciliter
Standard Deviation 15.16
|
|
Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 6
|
-31.20 milligram per deciliter
Standard Deviation 20.31
|
-35.90 milligram per deciliter
Standard Deviation 22.27
|
|
Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 7
|
-36.40 milligram per deciliter
Standard Deviation 24.50
|
-47.60 milligram per deciliter
Standard Deviation 24.04
|
|
Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 15
|
-62.50 milligram per deciliter
Standard Deviation 39.40
|
-30.10 milligram per deciliter
Standard Deviation 36.18
|
|
Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 22
|
-68.80 milligram per deciliter
Standard Deviation 32.78
|
4.70 milligram per deciliter
Standard Deviation 40.14
|
|
Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 29
|
-69.00 milligram per deciliter
Standard Deviation 35.01
|
7.90 milligram per deciliter
Standard Deviation 39.76
|
|
Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 57
|
6.50 milligram per deciliter
Standard Deviation 32.76
|
14.30 milligram per deciliter
Standard Deviation 39.36
|
|
Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 64
|
12.10 milligram per deciliter
Standard Deviation 20.13
|
12.70 milligram per deciliter
Standard Deviation 35.12
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 57
|
26.20 milligram per deciliter
Standard Deviation 63.42
|
16.50 milligram per deciliter
Standard Deviation 56.65
|
|
Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 5
|
9.20 milligram per deciliter
Standard Deviation 61.82
|
-15.80 milligram per deciliter
Standard Deviation 38.46
|
|
Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 6
|
11.70 milligram per deciliter
Standard Deviation 24.23
|
-9.90 milligram per deciliter
Standard Deviation 31.22
|
|
Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 7
|
8.10 milligram per deciliter
Standard Deviation 38.09
|
-6.90 milligram per deciliter
Standard Deviation 44.25
|
|
Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 15
|
-19.60 milligram per deciliter
Standard Deviation 41.40
|
-21.10 milligram per deciliter
Standard Deviation 56.39
|
|
Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 22
|
-4.30 milligram per deciliter
Standard Deviation 45.63
|
13.60 milligram per deciliter
Standard Deviation 52.71
|
|
Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 29
|
-17.40 milligram per deciliter
Standard Deviation 21.51
|
-8.20 milligram per deciliter
Standard Deviation 60.64
|
|
Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 36
|
-22.20 milligram per deciliter
Standard Deviation 54.24
|
-0.30 milligram per deciliter
Standard Deviation 70.24
|
|
Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 43
|
-13.10 milligram per deciliter
Standard Deviation 42.48
|
-10.90 milligram per deciliter
Standard Deviation 64.52
|
|
Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 50
|
11.60 milligram per deciliter
Standard Deviation 57.86
|
-4.90 milligram per deciliter
Standard Deviation 79.62
|
|
Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 64
|
29.60 milligram per deciliter
Standard Deviation 53.23
|
3.10 milligram per deciliter
Standard Deviation 31.78
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 43
|
-27.30 milligram per deciliter
Standard Deviation 7.48
|
-0.60 milligram per deciliter
Standard Deviation 18.47
|
|
Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 50
|
-10.40 milligram per deciliter
Standard Deviation 10.53
|
-4.60 milligram per deciliter
Standard Deviation 20.74
|
|
Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 57
|
-5.10 milligram per deciliter
Standard Deviation 15.70
|
4.70 milligram per deciliter
Standard Deviation 15.51
|
|
Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 5
|
-10.90 milligram per deciliter
Standard Deviation 7.48
|
-13.10 milligram per deciliter
Standard Deviation 8.49
|
|
Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 6
|
-22.10 milligram per deciliter
Standard Deviation 10.05
|
-24.90 milligram per deciliter
Standard Deviation 12.88
|
|
Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 7
|
-28.30 milligram per deciliter
Standard Deviation 12.57
|
-29.50 milligram per deciliter
Standard Deviation 16.75
|
|
Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 15
|
-41.90 milligram per deciliter
Standard Deviation 19.41
|
-21.70 milligram per deciliter
Standard Deviation 19.84
|
|
Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 22
|
-44.00 milligram per deciliter
Standard Deviation 17.67
|
-3.30 milligram per deciliter
Standard Deviation 18.78
|
|
Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 29
|
-45.80 milligram per deciliter
Standard Deviation 17.61
|
-1.10 milligram per deciliter
Standard Deviation 23.99
|
|
Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 36
|
-41.10 milligram per deciliter
Standard Deviation 15.09
|
-2.70 milligram per deciliter
Standard Deviation 19.76
|
|
Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 64
|
2.30 milligram per deciliter
Standard Deviation 10.70
|
5.80 milligram per deciliter
Standard Deviation 20.99
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 50
|
6.50 milligram per deciliter
Standard Deviation 8.64
|
5.20 milligram per deciliter
Standard Deviation 22.03
|
|
Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 57
|
4.40 milligram per deciliter
Standard Deviation 11.77
|
24.50 milligram per deciliter
Standard Deviation 12.51
|
|
Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 5
|
-3.00 milligram per deciliter
Standard Deviation 10.95
|
2.80 milligram per deciliter
Standard Deviation 8.70
|
|
Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 6
|
-1.70 milligram per deciliter
Standard Deviation 10.79
|
-5.60 milligram per deciliter
Standard Deviation 8.07
|
|
Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 7
|
3.40 milligram per deciliter
Standard Deviation 10.93
|
-1.50 milligram per deciliter
Standard Deviation 9.22
|
|
Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 15
|
6.80 milligram per deciliter
Standard Deviation 8.30
|
12.10 milligram per deciliter
Standard Deviation 18.48
|
|
Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 22
|
5.70 milligram per deciliter
Standard Deviation 11.13
|
16.10 milligram per deciliter
Standard Deviation 18.71
|
|
Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 29
|
7.50 milligram per deciliter
Standard Deviation 13.43
|
11.40 milligram per deciliter
Standard Deviation 27.34
|
|
Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 36
|
10.30 milligram per deciliter
Standard Deviation 10.87
|
11.50 milligram per deciliter
Standard Deviation 15.09
|
|
Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 43
|
7.80 milligram per deciliter
Standard Deviation 10.73
|
14.90 milligram per deciliter
Standard Deviation 15.96
|
|
Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 64
|
0.50 milligram per deciliter
Standard Deviation 10.82
|
22.10 milligram per deciliter
Standard Deviation 19.44
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 15
|
4.50 milligram per deciliter
Standard Deviation 8.01
|
5.90 milligram per deciliter
Standard Deviation 5.13
|
|
Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 22
|
6.70 milligram per deciliter
Standard Deviation 4.65
|
2.80 milligram per deciliter
Standard Deviation 5.41
|
|
Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 29
|
6.50 milligram per deciliter
Standard Deviation 6.53
|
0.50 milligram per deciliter
Standard Deviation 5.99
|
|
Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 36
|
3.80 milligram per deciliter
Standard Deviation 5.52
|
1.90 milligram per deciliter
Standard Deviation 8.20
|
|
Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 43
|
6.10 milligram per deciliter
Standard Deviation 6.59
|
3.10 milligram per deciliter
Standard Deviation 5.39
|
|
Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 50
|
2.80 milligram per deciliter
Standard Deviation 6.27
|
1.70 milligram per deciliter
Standard Deviation 7.71
|
|
Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 57
|
2.70 milligram per deciliter
Standard Deviation 5.26
|
4.20 milligram per deciliter
Standard Deviation 9.22
|
|
Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 5
|
-1.30 milligram per deciliter
Standard Deviation 5.60
|
-2.20 milligram per deciliter
Standard Deviation 7.95
|
|
Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 6
|
-2.10 milligram per deciliter
Standard Deviation 4.16
|
-2.40 milligram per deciliter
Standard Deviation 11.71
|
|
Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 7
|
-0.90 milligram per deciliter
Standard Deviation 4.41
|
-2.40 milligram per deciliter
Standard Deviation 12.63
|
|
Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Change at Day 64
|
-0.0 milligram per deciliter
Standard Deviation 6.02
|
2.40 milligram per deciliter
Standard Deviation 7.95
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 64
|
13.40 percent change
Standard Deviation 31.22
|
25.60 percent change
Standard Deviation 42.94
|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 5
|
-15.70 percent change
Standard Deviation 23.36
|
-27.30 percent change
Standard Deviation 23.60
|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 6
|
-33.80 percent change
Standard Deviation 20.61
|
-47.00 percent change
Standard Deviation 30.57
|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 7
|
-38.90 percent change
Standard Deviation 24.15
|
-65.10 percent change
Standard Deviation 31.82
|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 15
|
-61.10 percent change
Standard Deviation 31.98
|
-33.30 percent change
Standard Deviation 29.80
|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 22
|
-71.60 percent change
Standard Deviation 21.89
|
11.40 percent change
Standard Deviation 46.23
|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 29
|
-68.70 percent change
Standard Deviation 22.20
|
21.60 percent change
Standard Deviation 46.26
|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 36
|
-68.20 percent change
Standard Deviation 15.59
|
14.90 percent change
Standard Deviation 36.90
|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 43
|
-41.80 percent change
Standard Deviation 18.87
|
19.70 percent change
Standard Deviation 38.86
|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 50
|
-14.70 percent change
Standard Deviation 17.10
|
13.70 percent change
Standard Deviation 37.36
|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 57
|
1.40 percent change
Standard Deviation 24.80
|
23.60 percent change
Standard Deviation 47.93
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 5
|
-8.30 percent change
Standard Deviation 11.81
|
-14.60 percent change
Standard Deviation 8.87
|
|
Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 6
|
-21.20 percent change
Standard Deviation 10.16
|
-26.20 percent change
Standard Deviation 10.56
|
|
Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 7
|
-23.10 percent change
Standard Deviation 14.16
|
-34.10 percent change
Standard Deviation 11.39
|
|
Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 57
|
7.50 percent change
Standard Deviation 19.31
|
14.30 percent change
Standard Deviation 20.05
|
|
Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 64
|
10.10 percent change
Standard Deviation 14.86
|
12.50 percent change
Standard Deviation 18.07
|
|
Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 15
|
-35.40 percent change
Standard Deviation 19.65
|
-14.40 percent change
Standard Deviation 18.89
|
|
Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 22
|
-38.40 percent change
Standard Deviation 16.70
|
7.40 percent change
Standard Deviation 21.95
|
|
Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 29
|
-39.40 percent change
Standard Deviation 14.50
|
7.40 percent change
Standard Deviation 19.86
|
|
Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 36
|
-36.30 percent change
Standard Deviation 14.00
|
7.00 percent change
Standard Deviation 21.50
|
|
Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 43
|
-18.90 percent change
Standard Deviation 10.34
|
9.00 percent change
Standard Deviation 21.22
|
|
Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 50
|
-3.70 percent change
Standard Deviation 11.17
|
6.00 percent change
Standard Deviation 19.62
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 6
|
-28.70 percent change
Standard Deviation 16.69
|
-37.60 percent change
Standard Deviation 26.74
|
|
Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 29
|
-63.90 percent change
Standard Deviation 17.86
|
16.10 percent change
Standard Deviation 40.69
|
|
Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 36
|
-57.30 percent change
Standard Deviation 16.60
|
14.00 percent change
Standard Deviation 36.59
|
|
Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 50
|
-9.40 percent change
Standard Deviation 16.55
|
12.90 percent change
Standard Deviation 38.29
|
|
Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 5
|
-9.90 percent change
Standard Deviation 20.47
|
-20.30 percent change
Standard Deviation 15.38
|
|
Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 7
|
-32.80 percent change
Standard Deviation 18.81
|
-50.00 percent change
Standard Deviation 26.78
|
|
Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 15
|
-56.00 percent change
Standard Deviation 26.05
|
-25.40 percent change
Standard Deviation 26.16
|
|
Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 22
|
-63.90 percent change
Standard Deviation 18.00
|
14.70 percent change
Standard Deviation 40.72
|
|
Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 43
|
-35.70 percent change
Standard Deviation 16.64
|
14.30 percent change
Standard Deviation 35.80
|
|
Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 57
|
7.80 percent change
Standard Deviation 26.93
|
23.80 percent change
Standard Deviation 44.36
|
|
Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 64
|
15.60 percent change
Standard Deviation 20.30
|
21.20 percent change
Standard Deviation 35.27
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 7
|
5.00 percent change
Standard Deviation 21.20
|
0.50 percent change
Standard Deviation 27.67
|
|
Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 15
|
-6.10 percent change
Standard Deviation 41.62
|
-1.40 percent change
Standard Deviation 35.76
|
|
Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 5
|
11.20 percent change
Standard Deviation 65.46
|
-3.30 percent change
Standard Deviation 24.88
|
|
Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 6
|
7.40 percent change
Standard Deviation 20.29
|
1.10 percent change
Standard Deviation 22.05
|
|
Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 22
|
-2.20 percent change
Standard Deviation 30.73
|
19.90 percent change
Standard Deviation 42.17
|
|
Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 29
|
-14.60 percent change
Standard Deviation 20.02
|
0.80 percent change
Standard Deviation 34.11
|
|
Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 36
|
-15.90 percent change
Standard Deviation 32.23
|
12.20 percent change
Standard Deviation 45.69
|
|
Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 43
|
-7.90 percent change
Standard Deviation 25.94
|
3.20 percent change
Standard Deviation 33.05
|
|
Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 50
|
12.60 percent change
Standard Deviation 42.61
|
12.10 percent change
Standard Deviation 49.12
|
|
Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 57
|
20.10 percent change
Standard Deviation 45.52
|
22.20 percent change
Standard Deviation 41.65
|
|
Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 64
|
28.60 percent change
Standard Deviation 42.51
|
7.60 percent change
Standard Deviation 30.24
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 6
|
-26.90 percent change
Standard Deviation 11.01
|
-31.10 percent change
Standard Deviation 13.84
|
|
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 7
|
-33.80 percent change
Standard Deviation 12.27
|
-36.10 percent change
Standard Deviation 15.68
|
|
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 43
|
-33.80 percent change
Standard Deviation 8.98
|
2.70 percent change
Standard Deviation 18.81
|
|
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 50
|
-13.70 percent change
Standard Deviation 13.70
|
-1.50 percent change
Standard Deviation 21.38
|
|
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 57
|
-5.80 percent change
Standard Deviation 18.03
|
9.40 percent change
Standard Deviation 19.89
|
|
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 5
|
-13.50 percent change
Standard Deviation 9.25
|
-17.10 percent change
Standard Deviation 11.22
|
|
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 15
|
-48.60 percent change
Standard Deviation 13.82
|
-24.80 percent change
Standard Deviation 18.18
|
|
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 22
|
-51.50 percent change
Standard Deviation 11.04
|
-0.70 percent change
Standard Deviation 19.21
|
|
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 29
|
-53.70 percent change
Standard Deviation 10.37
|
3.80 percent change
Standard Deviation 26.31
|
|
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 36
|
-48.80 percent change
Standard Deviation 9.97
|
1.50 percent change
Standard Deviation 22.64
|
|
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 64
|
3.00 percent change
Standard Deviation 12.82
|
11.50 percent change
Standard Deviation 25.50
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 64
|
0.50 percent change
Standard Deviation 12.37
|
8.20 percent change
Standard Deviation 12.15
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 6
|
-3.60 percent change
Standard Deviation 8.24
|
-0.90 percent change
Standard Deviation 18.31
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 7
|
-1.10 percent change
Standard Deviation 9.29
|
-0.90 percent change
Standard Deviation 18.01
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 15
|
11.10 percent change
Standard Deviation 19.48
|
13.40 percent change
Standard Deviation 12.40
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 22
|
13.90 percent change
Standard Deviation 9.65
|
8.00 percent change
Standard Deviation 11.23
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 29
|
14.00 percent change
Standard Deviation 15.04
|
3.00 percent change
Standard Deviation 11.72
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 36
|
7.80 percent change
Standard Deviation 11.50
|
7.50 percent change
Standard Deviation 17.15
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 43
|
14.50 percent change
Standard Deviation 15.67
|
8.70 percent change
Standard Deviation 8.79
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 50
|
6.10 percent change
Standard Deviation 13.89
|
6.70 percent change
Standard Deviation 14.20
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 57
|
6.10 percent change
Standard Deviation 11.93
|
14.00 percent change
Standard Deviation 19.37
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 5
|
-2.50 percent change
Standard Deviation 11.27
|
-1.70 percent change
Standard Deviation 10.93
|
SECONDARY outcome
Timeframe: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 5
|
-1.90 percent change
Standard Deviation 7.48
|
2.10 percent change
Standard Deviation 6.61
|
|
Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 6
|
-1.00 percent change
Standard Deviation 7.27
|
-4.20 percent change
Standard Deviation 6.80
|
|
Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 15
|
5.10 percent change
Standard Deviation 6.31
|
9.10 percent change
Standard Deviation 12.52
|
|
Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 22
|
4.40 percent change
Standard Deviation 8.27
|
11.50 percent change
Standard Deviation 11.39
|
|
Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 7
|
2.90 percent change
Standard Deviation 7.14
|
-0.80 percent change
Standard Deviation 7.97
|
|
Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 43
|
5.80 percent change
Standard Deviation 7.73
|
11.60 percent change
Standard Deviation 12.44
|
|
Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 50
|
4.50 percent change
Standard Deviation 5.77
|
3.50 percent change
Standard Deviation 16.45
|
|
Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 57
|
3.40 percent change
Standard Deviation 8.71
|
18.80 percent change
Standard Deviation 7.84
|
|
Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 64
|
0.80 percent change
Standard Deviation 7.48
|
16.90 percent change
Standard Deviation 14.18
|
|
Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 29
|
5.20 percent change
Standard Deviation 9.94
|
7.80 percent change
Standard Deviation 17.55
|
|
Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Percent change at Day 36
|
7.30 percent change
Standard Deviation 7.64
|
8.80 percent change
Standard Deviation 11.09
|
SECONDARY outcome
Timeframe: Day 4 to Day 64Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.
In this outcome measure duration of the lipid-lowering effects was reported. Lipid lowering was defined as decrease in LDL-C levels by greater than or equal to 15 percent.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Duration of Low Density Lipoprotein (LDL) Lowering Effects
|
48.5 days
Full Range 16.36 • Interval 2.0 to 64.0
|
18.0 days
Full Range 15.68 • Interval 0.0 to 59.0
|
SECONDARY outcome
Timeframe: Day 1 up to Day 64Population: Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.
Toxicity criteria included any of the following: serious adverse event; increased liver transaminases (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\]: increased to greater than \[\>\] 5\*upper limit of normal reference range \[ULN\]); increased bilirubin (in absence of ALT or AST elevations, common terminology criteria for adverse events \[CTCAE\] greater than or equal to \[\>=\] Grade 2); pancreatitis, increased serum creatinine (CTCAE \>= Grade 2); creatine kinase, hyperglycemia or hypoglycemia, diarrhea or enteritis or nausea (CTCAE \>= Grade 3); decreased platelet count (less than \[\<\] 100000 per microliter); prolongation of QT interval with Fridericia's Correction (QTcF) (QTcF \>500 millisecond \[msec\] \[CTCAE \>= Grade 3\] or increase from baseline of \>=60 msec) and other considered appropriate by investigator. CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Number of Participants With Toxicity or Intolerable Dose Criteria
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 64Population: Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. Adverse events included both serious and non-serious adverse events.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
12 Participants
|
11 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 64Population: Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. AEs were assessed for severity by CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event. Categories with at least 1 participant were reported
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events by Severity
Grade 3 AEs
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by Severity
Grade 1 AEs
|
5 Participants
|
8 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by Severity
Grade 2 AEs
|
4 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by Severity
Unknown
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 64Population: Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
6 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 64Population: Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. Complete physical examination was conducted to assess skin, ears, throat, cardiac, respiratory, gastrointestinal, and musculoskeletal systems for systemic AEs.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Physical Examination
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 64Population: Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. Vital sign parameters body temperature, blood pressure and heart rate were assessed to identify systemic adverse events. AEs (all causalities), treatment related AEs and CTCAE severity grades for AEs were reported. CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event. Categories with at least 1 participant were reported
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital Signs
Treatment related AEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital Signs
Grade 1 AEs: (All causalities)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital Signs
Grade 2 AEs: (All causalities)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital Signs
AEs (All causalities)
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 64Population: Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. ECG parameters RR interval, PR interval, QRS complex, QT interval, \[Bazett's Correction\], QTcF interval \[Fridericia's Correction\] were assessed to identify systemic AEs. AEs (all causalities), treatment related AEs and CTCAE severity grades for AEs were reported. CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event. Categories with at least 1 participant were reported.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Electrocardiogram (ECG) Parameters
AEs (All causalities)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Electrocardiogram (ECG) Parameters
Treatment related AEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Electrocardiogram (ECG) Parameters
Grade 1 AEs: (All causalities)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 64Population: Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.
Laboratory parameters alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, albumin, hemoglobin, protein, amylase, creatine kinase, lipase, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets, white blood cells, bicarbonate, chloride, potassium, sodium, bilirubin, blood urea nitrogen, c-reactive protein , calcium, creatinine, direct bilirubin, glucose, magnesium, phosphate, uric acid, hematocrit, partial thromboplastin time , prothrombin time, red blood cells , urine pH, urine specific gravity were assessed to identify systemic AEs. AEs (all causalities), treatment related AEs and CTCAE severity grades for AEs were reported. Same participant may be reported in more than 1 CTCAE severity grade. Categories with at least 1 participant were reported.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters
Grade 1 AEs: (All causalities)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters
Grade 1 AEs: (Treatment related)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters
AEs (All causalities)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters
Treatment related AEs
|
2 Participants
|
0 Participants
|
|
Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters
Grade 2 AEs: (Treatment related)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters
Grade 3 AEs: (Treatment related)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 64Population: Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.
Human serum ADA samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 (RN316) antibodies. Results with titer value \>=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure.
Outcome measures
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 Participants
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Number of Participants With Positive Anti-drug Antibodies (ADA)
|
4 Participants
|
0 Participants
|
Adverse Events
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 participants at risk
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 participants at risk
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Nervous system disorders
Headache
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
PF-04950615 (RN316) 4 mg/kg + Atorvastatin
n=12 participants at risk
Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin
n=12 participants at risk
Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Ear pain
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chills
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
16.7%
2/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site erythema
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oral herpes
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Viral infection
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngitis
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood amylase increased
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood lactate dehydrogenase increased
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood pressure increased
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Heart rate increased
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Lipase increased
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
White blood cell count decreased
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
25.0%
3/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
33.3%
4/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Sinus headache
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Dysuria
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Pelvic pain
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
2/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Flushing
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hot flush
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Phlebitis
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER