Trial Outcomes & Findings for Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females (NCT NCT01301456)
NCT ID: NCT01301456
Last Updated: 2018-02-09
Results Overview
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 28 days after last dose (Day 50) that were absent before treatment or that worsened relative to pretreatment state.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
84 participants
Primary outcome timeframe
Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
Results posted on
2018-02-09
Participant Flow
Data for reporting arm Placebo 1a and 1b in stage 1 was planned to be pooled during analysis, as per protocol. Study consisted of two stages: stage 1 and stage 2. Participants were enrolled and randomized for stage 1 and stage 2 separately.
Participant milestones
| Measure |
Stage 1: PF-04856883 Placebo
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
Participants received PF-04856883 4 milligram (mg) subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1
STARTED
|
15
|
5
|
6
|
6
|
7
|
5
|
8
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Received Treatment
|
15
|
5
|
6
|
6
|
7
|
5
|
7
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
COMPLETED
|
15
|
5
|
5
|
6
|
6
|
5
|
7
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
NOT COMPLETED
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
5
|
7
|
7
|
6
|
|
Stage 2
Received Treatment
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
5
|
7
|
7
|
6
|
|
Stage 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
5
|
7
|
6
|
6
|
|
Stage 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Stage 1: PF-04856883 Placebo
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
Participants received PF-04856883 4 milligram (mg) subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Randomized but not treated
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females
Baseline characteristics by cohort
| Measure |
Stage 1: PF-04856883 Placebo
n=15 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=6 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=6 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=7 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
n=5 Participants
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
n=8 Participants
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
n=7 Participants
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
n=5 Participants
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
n=7 Participants
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
n=7 Participants
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
n=6 Participants
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<18 years
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=40 Participants
|
0 participants
n=8 Participants
|
0 participants
n=62 Participants
|
0 participants
n=95 Participants
|
0 participants
n=129 Participants
|
0 participants
n=36 Participants
|
|
Age, Customized
Between 18 and 64 years
|
15 participants
n=93 Participants
|
3 participants
n=4 Participants
|
5 participants
n=27 Participants
|
4 participants
n=483 Participants
|
6 participants
n=36 Participants
|
4 participants
n=10 Participants
|
6 participants
n=115 Participants
|
6 participants
n=40 Participants
|
5 participants
n=8 Participants
|
4 participants
n=62 Participants
|
7 participants
n=95 Participants
|
6 participants
n=129 Participants
|
71 participants
n=36 Participants
|
|
Age, Customized
>=65 years
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
1 participants
n=27 Participants
|
2 participants
n=483 Participants
|
1 participants
n=36 Participants
|
1 participants
n=10 Participants
|
2 participants
n=115 Participants
|
1 participants
n=40 Participants
|
0 participants
n=8 Participants
|
3 participants
n=62 Participants
|
0 participants
n=95 Participants
|
0 participants
n=129 Participants
|
13 participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
7 Participants
n=40 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=62 Participants
|
7 Participants
n=95 Participants
|
6 Participants
n=129 Participants
|
84 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50Population: The safety population included all randomized participants who received at least 1 dose of study treatment.
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 28 days after last dose (Day 50) that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=15 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=6 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=6 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=7 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
n=5 Participants
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
n=7 Participants
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
n=7 Participants
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
n=5 Participants
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
n=7 Participants
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
n=7 Participants
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
n=6 Participants
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
SAE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
AE
|
8 participants
|
1 participants
|
0 participants
|
2 participants
|
4 participants
|
3 participants
|
4 participants
|
4 participants
|
5 participants
|
5 participants
|
5 participants
|
5 participants
|
PRIMARY outcome
Timeframe: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50Population: The safety population included all randomized participants who received at least 1 dose of study treatment.
Physical examination included examination of general appearance, head, ears, eyes (including fundoscopy), nose, mouth, throat, neck (including thyroid), skin, breast (optional), cardiac, respiratory, gastrointestinal, musculoskeletal and neurological systems.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=15 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=6 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=6 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=7 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
n=5 Participants
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
n=7 Participants
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
n=7 Participants
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
n=5 Participants
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
n=7 Participants
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
n=7 Participants
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
n=6 Participants
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Physical Examination Findings
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50Population: The safety population included all randomized participants who received at least 1 dose of study treatment.
ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). ECG criteria of clinically significant concern were 1) PR interval: greater than equal to (\>=) 25 percent (%) increase when baseline greater than (\>)200 milliseconds (msec); or increase \>=50% when baseline less than or equal to (\<=200) msec; 2) QRS interval: \>=25% increase when baseline \>100 msec; \>=50% increase when baseline \<= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) and Bazett's formula (QTcB interval): absolute value 450 - \<480 msec, 480 - \<500 msec \>=500; absolute change 30 - \<60, \>=60 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported. IFB = increase from baseline.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=15 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=6 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=6 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=7 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
n=5 Participants
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
n=7 Participants
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
n=7 Participants
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
n=5 Participants
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
n=7 Participants
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
n=7 Participants
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
n=6 Participants
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)
Maximum QTcF Interval IFB: 30-<60 msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)
Maximum PR Interval IFB: >=25 or 50%
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)
Maximum QTcB Interval IFB: 30-<60 msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50Population: The safety population included all randomized participants who received at least 1 dose of study treatment.
Criteria for vital signs abnormalities: sitting/supine systolic pulse rate less than (\<) 40 beats per minute (bpm) or greater than (\>) 120 bpm, standing/supine systolic pulse \< 40 bpm or \> 140 bpm, systolic blood pressure of \>=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure \<90 mmHg, diastolic blood pressure \>=20 mmHg change from baseline and diastolic blood pressure \<50 mm Hg.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=15 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=6 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=6 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=7 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
n=5 Participants
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
n=7 Participants
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
n=7 Participants
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
n=5 Participants
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
n=7 Participants
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
n=7 Participants
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
n=6 Participants
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Abnormalities
|
15 participants
|
5 participants
|
6 participants
|
6 participants
|
7 participants
|
5 participants
|
7 participants
|
7 participants
|
5 participants
|
7 participants
|
7 participants
|
6 participants
|
PRIMARY outcome
Timeframe: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50Population: The safety population included all randomized participants who received at least 1 dose of study treatment.
Following parameters were analyzed for laboratory examination: Hematology: hemoglobin, hematocrit, red blood cell (RBC) \<0.8\*lower limit of the reference range (LLRR); leukocytes \<0.6\*LLRR or \>1.5\*ULRR; platelet count \<0.5\*LLRR or \>1.75\*upper limit of the reference range (ULRR); total neutrophils (absolute \[abs\]), lymphocytes (abs) \<0.8\*LLRR or \>1.2\*ULRR; eosinophils (abs), basophils (abs), monocytes (abs) \>1.2\*ULRR; chemistry (total bilirubin, direct bilirubin, indirect bilirubin \>1.5\*ULRR; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase \>3\*ULRR, albumin, total protein \<0.8\*LLRR or \>1.2\*ULRR; blood urea nitrogen (BUN), creatinine \>1.3\*ULRR; glucose (fasting) \<0.6\*LLRR or \>1.5\*ULRR; uric acid \>1.2\* ULRR; sodium \<0.95\*LLRR or \>1.05\*ULRR; potassium, chloride, bicarbonate, calcium \<0.9\*LLRR or \>1.1\*ULRR. Urinalysis: Urine white blood cell (WBC), Urine RBC =\>20/ high-power field (HPF).
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=15 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=6 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=6 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=7 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
n=5 Participants
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
n=7 Participants
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
n=7 Participants
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
n=5 Participants
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
n=7 Participants
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
n=7 Participants
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
n=6 Participants
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements
|
15 participants
|
5 participants
|
6 participants
|
6 participants
|
7 participants
|
4 participants
|
6 participants
|
7 participants
|
5 participants
|
7 participants
|
7 participants
|
6 participants
|
SECONDARY outcome
Timeframe: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1Population: Pharmacokinetic (PK) parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=5 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=6 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=6 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=7 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=5 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
n=7 Participants
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1
|
181.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 85
|
324.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 61
|
793.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 65
|
1855 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 66
|
1776 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 21
|
2006 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 52
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=5 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=7 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=7 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=6 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2
Day 1 (n =5, 7, 7, 6)
|
1369 ng/mL
Geometric Coefficient of Variation 17
|
1203 ng/mL
Geometric Coefficient of Variation 20
|
1027 ng/mL
Geometric Coefficient of Variation 29
|
1407 ng/mL
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2
Day 22 (n =5, 7, 5, 6)
|
1802 ng/mL
Geometric Coefficient of Variation 33
|
2757 ng/mL
Geometric Coefficient of Variation 26
|
3030 ng/mL
Geometric Coefficient of Variation 42
|
3046 ng/mL
Geometric Coefficient of Variation 24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=5 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=6 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=6 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=7 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=5 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
n=7 Participants
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1
|
168 hour
Interval 72.0 to 336.0
|
120 hour
Interval 48.0 to 168.0
|
120 hour
Interval 48.0 to 168.0
|
120 hour
Interval 48.0 to 120.0
|
120 hour
Interval 72.0 to 168.0
|
122 hour
Interval 120.0 to 168.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=5 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=7 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=7 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=6 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2
Day 1 (n =5, 7, 7, 6)
|
336 hour
Interval 336.0 to 336.0
|
336 hour
Interval 335.0 to 336.0
|
335 hour
Interval 24.1 to 336.0
|
336 hour
Interval 336.0 to 336.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2
Day 22 (n =5, 7, 5, 6)
|
48.0 hour
Interval 24.0 to 72.0
|
72.0 hour
Interval 0.0 to 72.0
|
72.0 hour
Interval 48.0 to 72.1
|
60.0 hour
Interval 0.0 to 120.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=3 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=3 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=4 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=5 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=3 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
n=3 Participants
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1
|
44920 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 112
|
95190 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 76
|
295200 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 46
|
527100 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 53
|
711300 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 13
|
652000 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 50
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168 hours postdose Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168 hours postdose Day 22Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Area under the serum concentration-time curve from time 0 to tau (AUCtau), where tau was the dosing interval of 168 hours.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=5 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=7 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=7 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=6 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2
Day 1 (n =5, 7, 7, 6)
|
85370 ng*hr/mL
Geometric Coefficient of Variation 38
|
99780 ng*hr/mL
Geometric Coefficient of Variation 41
|
89390 ng*hr/mL
Geometric Coefficient of Variation 35
|
91130 ng*hr/mL
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2
Day 22 (n =5, 7, 5, 6)
|
269000 ng*hr/mL
Geometric Coefficient of Variation 32
|
377400 ng*hr/mL
Geometric Coefficient of Variation 28
|
396300 ng*hr/mL
Geometric Coefficient of Variation 28
|
430500 ng*hr/mL
Geometric Coefficient of Variation 23
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure.
It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 1 only.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=3 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=3 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=4 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=5 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=3 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
n=3 Participants
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of PF-04856883: Stage 1
|
89.14 milliliter per hour (mL/hr)
Geometric Coefficient of Variation 84
|
84.08 milliliter per hour (mL/hr)
Geometric Coefficient of Variation 59
|
40.60 milliliter per hour (mL/hr)
Geometric Coefficient of Variation 68
|
34.13 milliliter per hour (mL/hr)
Geometric Coefficient of Variation 35
|
33.73 milliliter per hour (mL/hr)
Geometric Coefficient of Variation 14
|
55.32 milliliter per hour (mL/hr)
Geometric Coefficient of Variation 42
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure.
It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 2 only. Data was not estimable if values were below the limit of quantification.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=5 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=7 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=7 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=6 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of PF-04856883: Stage 2
|
44.67 mL/hr
Geometric Coefficient of Variation 28
|
NA mL/hr
Geometric Coefficient of Variation NA
Data was not estimable since values were below the limit of quantification.
|
NA mL/hr
Geometric Coefficient of Variation NA
Data was not estimable since values were below the limit of quantification.
|
NA mL/hr
Geometric Coefficient of Variation NA
Data was not estimable since values were below the limit of quantification.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=3 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=3 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=4 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=5 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=3 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
n=3 Participants
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1
|
18760 milliliter (mL)
Geometric Coefficient of Variation 90
|
21710 milliliter (mL)
Geometric Coefficient of Variation 59
|
9191 milliliter (mL)
Geometric Coefficient of Variation 51
|
7127 milliliter (mL)
Geometric Coefficient of Variation 40
|
8437 milliliter (mL)
Geometric Coefficient of Variation 17
|
10010 milliliter (mL)
Geometric Coefficient of Variation 67
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=5 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=7 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=7 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=6 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2
|
9550 mL
Geometric Coefficient of Variation 29
|
NA mL
Geometric Coefficient of Variation NA
Data was not estimable since values were below the limit of quantification.
|
NA mL
Geometric Coefficient of Variation NA
Data was not estimable since values were below the limit of quantification.
|
NA mL
Geometric Coefficient of Variation NA
Data was not estimable since values were below the limit of quantification.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=3 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=3 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=3 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=4 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=3 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
n=3 Participants
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1
|
146.3 hour
Standard Deviation 13.614
|
179.7 hour
Standard Deviation 14.572
|
147.0 hour
Standard Deviation 18.520
|
133.8 hour
Standard Deviation 23.936
|
173.7 hour
Standard Deviation 7.0238
|
131.6 hour
Standard Deviation 45.883
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=5 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=4 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=5 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2
|
149.4 hour
Standard Deviation 21.870
|
135.0 hour
Standard Deviation 43.980
|
143.8 hour
Standard Deviation 20.565
|
145.0 hour
Standard Deviation 37.000
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 3 and 8Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=15 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=6 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=6 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=7 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
n=5 Participants
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
n=7 Participants
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Baseline (n =15, 5, 6, 6, 7, 5, 7)
|
656.35 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 114.496
|
834.03 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 158.952
|
712.11 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 88.942
|
796.14 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 208.733
|
660.64 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 110.833
|
652.20 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 48.707
|
636.57 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 119.662
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6)
|
7.72 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 89.366
|
77.82 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 125.011
|
-89.38 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 58.909
|
-101.47 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 31.725
|
-68.05 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 111.431
|
-141.27 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 15.975
|
-153.04 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 41.501
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Change at Day 8 (n =15, 5, 5, 6, 7, 5, 6)
|
-4.82 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 75.396
|
10.37 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 158.368
|
0.85 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 125.384
|
-82.51 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 48.898
|
-28.36 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 61.456
|
-123.43 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 68.219
|
-39.60 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 85.256
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 3, 15, 24, 29 and 50Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=7 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=7 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=7 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=6 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Baseline (n =7, 4, 7, 7, 6)
|
606.49 mg*hr/dL
Standard Deviation 158.249
|
811.36 mg*hr/dL
Standard Deviation 131.145
|
756.17 mg*hr/dL
Standard Deviation 240.430
|
800.66 mg*hr/dL
Standard Deviation 206.776
|
723.57 mg*hr/dL
Standard Deviation 220.872
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Change at Day 3 (n =7, 4, 5, 6, 5)
|
44.41 mg*hr/dL
Standard Deviation 74.405
|
-97.03 mg*hr/dL
Standard Deviation 55.692
|
-103.00 mg*hr/dL
Standard Deviation 118.759
|
-98.38 mg*hr/dL
Standard Deviation 114.644
|
-68.52 mg*hr/dL
Standard Deviation 153.127
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Change at Day 15 (n =7, 4, 6, 6, 6)
|
-18.48 mg*hr/dL
Standard Deviation 50.874
|
-265.64 mg*hr/dL
Standard Deviation 89.889
|
-293.04 mg*hr/dL
Standard Deviation 163.074
|
-254.54 mg*hr/dL
Standard Deviation 144.897
|
-240.65 mg*hr/dL
Standard Deviation 252.349
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Change at Day 24 (n =7, 4, 7, 6, 5)
|
-6.20 mg*hr/dL
Standard Deviation 46.238
|
-146.61 mg*hr/dL
Standard Deviation 78.863
|
-207.12 mg*hr/dL
Standard Deviation 89.687
|
-242.35 mg*hr/dL
Standard Deviation 231.302
|
-121.13 mg*hr/dL
Standard Deviation 258.528
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Change at Day 29 (n =7, 4, 7, 6, 5)
|
30.08 mg*hr/dL
Standard Deviation 59.490
|
-55.43 mg*hr/dL
Standard Deviation 74.973
|
-157.54 mg*hr/dL
Standard Deviation 88.652
|
-192.97 mg*hr/dL
Standard Deviation 185.056
|
-106.58 mg*hr/dL
Standard Deviation 171.297
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Change at Day 50 (n =7, 3, 6, 6, 6)
|
50.26 mg*hr/dL
Standard Deviation 81.717
|
-48.82 mg*hr/dL
Standard Deviation 80.733
|
-33.77 mg*hr/dL
Standard Deviation 250.859
|
-125.06 mg*hr/dL
Standard Deviation 217.403
|
-23.99 mg*hr/dL
Standard Deviation 123.611
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 3 and 8Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=15 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=6 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=6 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=7 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
n=5 Participants
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
n=7 Participants
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Baseline (n =15, 5, 6, 6, 7, 5, 7)
|
222.18 milliUnit*hour per liter (mU*hr/L)
Standard Deviation 139.981
|
227.07 milliUnit*hour per liter (mU*hr/L)
Standard Deviation 142.547
|
210.80 milliUnit*hour per liter (mU*hr/L)
Standard Deviation 95.536
|
235.84 milliUnit*hour per liter (mU*hr/L)
Standard Deviation 130.071
|
105.34 milliUnit*hour per liter (mU*hr/L)
Standard Deviation 19.118
|
257.73 milliUnit*hour per liter (mU*hr/L)
Standard Deviation 127.358
|
283.59 milliUnit*hour per liter (mU*hr/L)
Standard Deviation 156.831
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6)
|
68.79 milliUnit*hour per liter (mU*hr/L)
Standard Deviation 115.555
|
22.99 milliUnit*hour per liter (mU*hr/L)
Standard Deviation 32.706
|
35.09 milliUnit*hour per liter (mU*hr/L)
Standard Deviation 57.093
|
12.15 milliUnit*hour per liter (mU*hr/L)
Standard Deviation 54.495
|
59.06 milliUnit*hour per liter (mU*hr/L)
Standard Deviation 94.643
|
83.82 milliUnit*hour per liter (mU*hr/L)
Standard Deviation 70.182
|
13.72 milliUnit*hour per liter (mU*hr/L)
Standard Deviation 98.682
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6)
|
34.23 milliUnit*hour per liter (mU*hr/L)
Standard Deviation 103.279
|
22.05 milliUnit*hour per liter (mU*hr/L)
Standard Deviation 89.419
|
39.96 milliUnit*hour per liter (mU*hr/L)
Standard Deviation 38.941
|
-50.51 milliUnit*hour per liter (mU*hr/L)
Standard Deviation 40.624
|
38.04 milliUnit*hour per liter (mU*hr/L)
Standard Deviation 15.736
|
-0.36 milliUnit*hour per liter (mU*hr/L)
Standard Deviation 50.674
|
1.08 milliUnit*hour per liter (mU*hr/L)
Standard Deviation 47.135
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 3, 15, 24, 29 and 50Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=7 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=7 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=7 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=6 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Baseline (n =7, 5, 7, 7, 6)
|
175.26 mU*hr/L
Standard Deviation 62.218
|
176.65 mU*hr/L
Standard Deviation 76.040
|
267.29 mU*hr/L
Standard Deviation 111.497
|
162.96 mU*hr/L
Standard Deviation 111.688
|
190.64 mU*hr/L
Standard Deviation 83.945
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Change at Day 3 (n =7, 5, 7, 7, 6)
|
38.32 mU*hr/L
Standard Deviation 62.135
|
13.29 mU*hr/L
Standard Deviation 55.764
|
19.50 mU*hr/L
Standard Deviation 134.651
|
27.99 mU*hr/L
Standard Deviation 32.655
|
87.67 mU*hr/L
Standard Deviation 124.052
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Change at Day 15 (n =7, 5, 7, 6, 6)
|
-16.77 mU*hr/L
Standard Deviation 20.530
|
-39.16 mU*hr/L
Standard Deviation 42.930
|
-10.07 mU*hr/L
Standard Deviation 172.044
|
-51.69 mU*hr/L
Standard Deviation 77.925
|
-24.36 mU*hr/L
Standard Deviation 85.633
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Change at Day 24 (n =7, 4, 7, 6, 6)
|
0.23 mU*hr/L
Standard Deviation 55.174
|
-15.19 mU*hr/L
Standard Deviation 38.900
|
6.87 mU*hr/L
Standard Deviation 184.830
|
4.18 mU*hr/L
Standard Deviation 51.903
|
60.11 mU*hr/L
Standard Deviation 189.287
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Change at Day 29 (n =7, 5, 7, 6, 5)
|
8.25 mU*hr/L
Standard Deviation 55.799
|
3.98 mU*hr/L
Standard Deviation 11.218
|
12.71 mU*hr/L
Standard Deviation 115.095
|
-1.61 mU*hr/L
Standard Deviation 85.866
|
15.70 mU*hr/L
Standard Deviation 38.476
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Change at Day 50 (n =7, 5, 7, 6, 5)
|
8.14 mU*hr/L
Standard Deviation 29.909
|
-16.64 mU*hr/L
Standard Deviation 33.133
|
-57.14 mU*hr/L
Standard Deviation 116.193
|
49.27 mU*hr/L
Standard Deviation 81.874
|
-26.78 mU*hr/L
Standard Deviation 81.518
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 3 and 8Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=15 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=6 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=6 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=7 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
n=5 Participants
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
n=7 Participants
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Baseline (n =15, 5, 6, 6, 7,5, 7)
|
15.53 ng*hr/mL
Standard Deviation 5.332
|
16.63 ng*hr/mL
Standard Deviation 7.743
|
16.43 ng*hr/mL
Standard Deviation 4.306
|
16.80 ng*hr/mL
Standard Deviation 5.711
|
10.64 ng*hr/mL
Standard Deviation 1.156
|
16.17 ng*hr/mL
Standard Deviation 4.531
|
18.37 ng*hr/mL
Standard Deviation 7.395
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6)
|
2.15 ng*hr/mL
Standard Deviation 3.653
|
0.69 ng*hr/mL
Standard Deviation 1.465
|
1.65 ng*hr/mL
Standard Deviation 4.958
|
1.05 ng*hr/mL
Standard Deviation 1.885
|
4.30 ng*hr/mL
Standard Deviation 4.102
|
5.34 ng*hr/mL
Standard Deviation 2.584
|
2.34 ng*hr/mL
Standard Deviation 4.333
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6)
|
0.79 ng*hr/mL
Standard Deviation 2.864
|
1.06 ng*hr/mL
Standard Deviation 1.806
|
0.83 ng*hr/mL
Standard Deviation 1.651
|
-2.74 ng*hr/mL
Standard Deviation 1.380
|
1.70 ng*hr/mL
Standard Deviation 1.544
|
-0.45 ng*hr/mL
Standard Deviation 2.883
|
-0.38 ng*hr/mL
Standard Deviation 1.565
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 3, 15, 24, 29 and 50Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=7 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=7 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=7 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=6 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Baseline (n =7, 5, 7, 7, 6)
|
13.47 ng*hr/mL
Standard Deviation 4.315
|
14.59 ng*hr/mL
Standard Deviation 4.205
|
15.63 ng*hr/mL
Standard Deviation 4.293
|
11.74 ng*hr/mL
Standard Deviation 5.210
|
14.14 ng*hr/mL
Standard Deviation 5.211
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Change at Day 3 (n =7, 5, 7, 7, 6)
|
1.68 ng*hr/mL
Standard Deviation 2.182
|
1.89 ng*hr/mL
Standard Deviation 4.705
|
0.50 ng*hr/mL
Standard Deviation 4.757
|
3.16 ng*hr/mL
Standard Deviation 1.613
|
3.49 ng*hr/mL
Standard Deviation 4.452
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Change at Day 15 (n =7, 5, 7, 6, 6)
|
-1.65 ng*hr/mL
Standard Deviation 1.493
|
-1.55 ng*hr/mL
Standard Deviation 2.821
|
-1.92 ng*hr/mL
Standard Deviation 6.930
|
-0.17 ng*hr/mL
Standard Deviation 4.135
|
-0.50 ng*hr/mL
Standard Deviation 4.871
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Change at Day 24 (n =7, 4, 7, 6, 6)
|
0.55 ng*hr/mL
Standard Deviation 3.518
|
0.71 ng*hr/mL
Standard Deviation 4.312
|
-0.99 ng*hr/mL
Standard Deviation 6.220
|
1.63 ng*hr/mL
Standard Deviation 2.994
|
1.21 ng*hr/mL
Standard Deviation 5.784
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Change at Day 29 (n =7, 5, 7, 6, 5)
|
0.10 ng*hr/mL
Standard Deviation 3.864
|
-0.07 ng*hr/mL
Standard Deviation 2.545
|
-0.59 ng*hr/mL
Standard Deviation 4.144
|
0.59 ng*hr/mL
Standard Deviation 2.733
|
0.41 ng*hr/mL
Standard Deviation 2.090
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Change at Day 50 (n =7, 5, 7, 6, 5)
|
-0.17 ng*hr/mL
Standard Deviation 1.978
|
-1.83 ng*hr/mL
Standard Deviation 2.015
|
-4.10 ng*hr/mL
Standard Deviation 5.265
|
1.06 ng*hr/mL
Standard Deviation 1.474
|
-2.90 ng*hr/mL
Standard Deviation 3.711
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 2, 4, 6, 15, 22 and 29Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=15 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=6 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=6 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=7 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
n=5 Participants
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
n=7 Participants
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1
Baseline (n =15, 5, 6, 6, 7, 5, 7)
|
161.67 milligram per deciliter (mg/dL)
Standard Deviation 27.102
|
219.60 milligram per deciliter (mg/dL)
Standard Deviation 44.557
|
171.17 milligram per deciliter (mg/dL)
Standard Deviation 23.752
|
174.00 milligram per deciliter (mg/dL)
Standard Deviation 48.949
|
168.57 milligram per deciliter (mg/dL)
Standard Deviation 38.336
|
145.60 milligram per deciliter (mg/dL)
Standard Deviation 21.606
|
158.14 milligram per deciliter (mg/dL)
Standard Deviation 35.362
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1
Change at Day 2 (n =15, 5, 6, 6, 7, 5, 7)
|
3.13 milligram per deciliter (mg/dL)
Standard Deviation 11.807
|
13.60 milligram per deciliter (mg/dL)
Standard Deviation 32.393
|
-18.67 milligram per deciliter (mg/dL)
Standard Deviation 21.011
|
-20.50 milligram per deciliter (mg/dL)
Standard Deviation 20.433
|
-22.14 milligram per deciliter (mg/dL)
Standard Deviation 34.090
|
-35.00 milligram per deciliter (mg/dL)
Standard Deviation 12.369
|
-29.71 milligram per deciliter (mg/dL)
Standard Deviation 30.804
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1
Change at Day 4 (n =15, 5, 5, 6, 7, 5, 6)
|
2.73 milligram per deciliter (mg/dL)
Standard Deviation 17.161
|
19.60 milligram per deciliter (mg/dL)
Standard Deviation 35.683
|
-12.40 milligram per deciliter (mg/dL)
Standard Deviation 17.358
|
-10.33 milligram per deciliter (mg/dL)
Standard Deviation 15.744
|
-30.71 milligram per deciliter (mg/dL)
Standard Deviation 13.841
|
-27.00 milligram per deciliter (mg/dL)
Standard Deviation 8.803
|
-28.33 milligram per deciliter (mg/dL)
Standard Deviation 21.942
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1
Change at Day 6 (n =15, 5, 4, 6, 7, 5, 7)
|
18.80 milligram per deciliter (mg/dL)
Standard Deviation 29.547
|
26.40 milligram per deciliter (mg/dL)
Standard Deviation 32.377
|
10.25 milligram per deciliter (mg/dL)
Standard Deviation 29.056
|
-8.33 milligram per deciliter (mg/dL)
Standard Deviation 27.156
|
-6.29 milligram per deciliter (mg/dL)
Standard Deviation 15.850
|
-16.80 milligram per deciliter (mg/dL)
Standard Deviation 19.176
|
-16.14 milligram per deciliter (mg/dL)
Standard Deviation 22.319
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1
Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7)
|
12.13 milligram per deciliter (mg/dL)
Standard Deviation 32.822
|
-13.80 milligram per deciliter (mg/dL)
Standard Deviation 46.949
|
23.80 milligram per deciliter (mg/dL)
Standard Deviation 56.857
|
19.33 milligram per deciliter (mg/dL)
Standard Deviation 16.476
|
8.00 milligram per deciliter (mg/dL)
Standard Deviation 21.223
|
3.40 milligram per deciliter (mg/dL)
Standard Deviation 27.309
|
-2.71 milligram per deciliter (mg/dL)
Standard Deviation 16.530
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1
Change at Day 22 (n =14, 4, 5, 6, 6, 5, 7)
|
11.00 milligram per deciliter (mg/dL)
Standard Deviation 28.205
|
23.75 milligram per deciliter (mg/dL)
Standard Deviation 61.163
|
33.40 milligram per deciliter (mg/dL)
Standard Deviation 76.064
|
11.17 milligram per deciliter (mg/dL)
Standard Deviation 26.446
|
2.17 milligram per deciliter (mg/dL)
Standard Deviation 15.065
|
1.20 milligram per deciliter (mg/dL)
Standard Deviation 18.847
|
-0.57 milligram per deciliter (mg/dL)
Standard Deviation 13.377
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1
Change at Day 29 (n =14, 5, 5, 6, 7, 5, 7)
|
22.00 milligram per deciliter (mg/dL)
Standard Deviation 33.439
|
1.60 milligram per deciliter (mg/dL)
Standard Deviation 27.763
|
27.80 milligram per deciliter (mg/dL)
Standard Deviation 29.575
|
0.33 milligram per deciliter (mg/dL)
Standard Deviation 16.978
|
1.57 milligram per deciliter (mg/dL)
Standard Deviation 21.220
|
-3.80 milligram per deciliter (mg/dL)
Standard Deviation 22.643
|
-2.29 milligram per deciliter (mg/dL)
Standard Deviation 19.551
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=7 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=7 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=7 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=6 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2
Baseline (n =7, 5, 7, 7, 6)
|
148.00 mg/dL
Standard Deviation 33.317
|
186.80 mg/dL
Standard Deviation 23.059
|
191.14 mg/dL
Standard Deviation 56.153
|
187.29 mg/dL
Standard Deviation 45.756
|
158.50 mg/dL
Standard Deviation 18.447
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2
Change at Day 2 (n =5, 4, 7, 7, 5)
|
3.00 mg/dL
Standard Deviation 15.281
|
-26.75 mg/dL
Standard Deviation 15.108
|
-15.14 mg/dL
Standard Deviation 21.217
|
-23.43 mg/dL
Standard Deviation 35.142
|
-10.40 mg/dL
Standard Deviation 18.461
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2
Change at Day 4 (n =5, 5, 7, 6, 6)
|
7.60 mg/dL
Standard Deviation 6.427
|
-14.80 mg/dL
Standard Deviation 24.284
|
-14.86 mg/dL
Standard Deviation 48.657
|
-20.33 mg/dL
Standard Deviation 22.818
|
-1.50 mg/dL
Standard Deviation 27.384
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2
Change at Day 6 (n =7, 4, 7, 7, 6)
|
-1.71 mg/dL
Standard Deviation 40.240
|
5.75 mg/dL
Standard Deviation 14.080
|
-44.86 mg/dL
Standard Deviation 38.451
|
-8.00 mg/dL
Standard Deviation 42.942
|
-15.83 mg/dL
Standard Deviation 8.909
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2
Change at Day 8 (n =6, 5, 7, 5, 6)
|
2.50 mg/dL
Standard Deviation 17.627
|
4.20 mg/dL
Standard Deviation 19.967
|
-37.43 mg/dL
Standard Deviation 42.383
|
2.60 mg/dL
Standard Deviation 73.449
|
24.50 mg/dL
Standard Deviation 47.618
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2
Change at Day 22 (n =7, 4, 7, 6, 6)
|
13.29 mg/dL
Standard Deviation 15.294
|
-4.25 mg/dL
Standard Deviation 13.817
|
-39.57 mg/dL
Standard Deviation 25.468
|
-14.17 mg/dL
Standard Deviation 38.270
|
-0.33 mg/dL
Standard Deviation 51.181
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2
Change at Day 23 (n =7, 4, 6, 6, 5)
|
7.71 mg/dL
Standard Deviation 23.894
|
-27.25 mg/dL
Standard Deviation 27.293
|
-40.33 mg/dL
Standard Deviation 18.327
|
-17.50 mg/dL
Standard Deviation 73.519
|
-24.00 mg/dL
Standard Deviation 29.967
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2
Change at Day 25 (n =7, 5, 6, 6, 5)
|
13.43 mg/dL
Standard Deviation 13.113
|
-16.60 mg/dL
Standard Deviation 43.443
|
-44.67 mg/dL
Standard Deviation 27.667
|
-23.33 mg/dL
Standard Deviation 52.936
|
-16.20 mg/dL
Standard Deviation 36.513
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2
Change at Day 27 (n =7, 5, 6, 6, 5)
|
8.57 mg/dL
Standard Deviation 21.110
|
-21.60 mg/dL
Standard Deviation 15.821
|
-37.33 mg/dL
Standard Deviation 17.963
|
-34.67 mg/dL
Standard Deviation 35.803
|
12.00 mg/dL
Standard Deviation 71.039
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2
Change at Day 30 (n =7, 5, 7, 6, 5)
|
2.43 mg/dL
Standard Deviation 12.739
|
-14.20 mg/dL
Standard Deviation 17.908
|
-22.29 mg/dL
Standard Deviation 26.171
|
-9.33 mg/dL
Standard Deviation 32.898
|
15.40 mg/dL
Standard Deviation 37.964
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2
Change at Day 36 (n =6, 5, 7, 6, 6)
|
-10.50 mg/dL
Standard Deviation 32.415
|
0.40 mg/dL
Standard Deviation 37.846
|
1.86 mg/dL
Standard Deviation 25.373
|
-5.83 mg/dL
Standard Deviation 32.009
|
27.67 mg/dL
Standard Deviation 59.594
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2
Change at Day 43 (n =7, 5, 5, 6, 6)
|
18.71 mg/dL
Standard Deviation 22.552
|
12.80 mg/dL
Standard Deviation 29.064
|
13.20 mg/dL
Standard Deviation 17.254
|
-1.17 mg/dL
Standard Deviation 41.787
|
8.33 mg/dL
Standard Deviation 18.991
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
A normalized area under the curve (NAUC) were computed by dividing the AUC by the amount of time between the last time point captured and the first time point captured.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=7 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=7 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=7 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=6 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2
Baseline (n =7, 5, 7, 7 ,6)
|
166.19 mg/dL
Standard Deviation 35.437
|
212.43 mg/dL
Standard Deviation 52.764
|
205.56 mg/dL
Standard Deviation 51.907
|
202.43 mg/dL
Standard Deviation 38.900
|
186.13 mg/dL
Standard Deviation 33.839
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2
Change at Day 30 (n =7, 5, 7, 6 ,5)
|
172.36 mg/dL
Standard Deviation 38.825
|
191.20 mg/dL
Standard Deviation 43.953
|
172.24 mg/dL
Standard Deviation 48.067
|
174.08 mg/dL
Standard Deviation 41.437
|
192.87 mg/dL
Standard Deviation 58.037
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 29 and 50Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
HbA1c is a measure of the glycosylated hemoglobin. Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Outcome measure was planned to analyzed only for Stage 2.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=7 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=7 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=7 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=6 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2
Day 29 (n =7, 5, 7, 6, 5)
|
0.06 percent
Standard Deviation 0.547
|
-0.24 percent
Standard Deviation 0.288
|
-0.41 percent
Standard Deviation 0.212
|
-0.42 percent
Standard Deviation 0.440
|
-0.40 percent
Standard Deviation 0.430
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2
Day 50 (n =6, 5, 7, 7, 6)
|
0.15 percent
Standard Deviation 0.769
|
-0.08 percent
Standard Deviation 0.335
|
-0.24 percent
Standard Deviation 0.326
|
-0.33 percent
Standard Deviation 0.754
|
-0.40 percent
Standard Deviation 0.580
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 15 and 29Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=15 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=6 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=6 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=7 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
n=5 Participants
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
n=7 Participants
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1
Baseline (n =15, 5, 6, 6, 7, 5, 7)
|
270.60 micromole per liter (mcmol/L)
Standard Deviation 34.618
|
289.20 micromole per liter (mcmol/L)
Standard Deviation 48.329
|
279.67 micromole per liter (mcmol/L)
Standard Deviation 30.507
|
304.83 micromole per liter (mcmol/L)
Standard Deviation 45.155
|
263.43 micromole per liter (mcmol/L)
Standard Deviation 34.942
|
259.80 micromole per liter (mcmol/L)
Standard Deviation 53.644
|
273.71 micromole per liter (mcmol/L)
Standard Deviation 36.036
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1
Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7)
|
1.13 micromole per liter (mcmol/L)
Standard Deviation 14.461
|
20.20 micromole per liter (mcmol/L)
Standard Deviation 10.986
|
4.20 micromole per liter (mcmol/L)
Standard Deviation 18.295
|
5.67 micromole per liter (mcmol/L)
Standard Deviation 13.095
|
4.29 micromole per liter (mcmol/L)
Standard Deviation 16.720
|
-13.60 micromole per liter (mcmol/L)
Standard Deviation 23.554
|
-12.29 micromole per liter (mcmol/L)
Standard Deviation 10.579
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1
Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7)
|
-5.67 micromole per liter (mcmol/L)
Standard Deviation 17.839
|
-20.40 micromole per liter (mcmol/L)
Standard Deviation 25.393
|
-16.40 micromole per liter (mcmol/L)
Standard Deviation 13.502
|
-9.17 micromole per liter (mcmol/L)
Standard Deviation 25.135
|
13.33 micromole per liter (mcmol/L)
Standard Deviation 24.188
|
-9.60 micromole per liter (mcmol/L)
Standard Deviation 22.267
|
-3.00 micromole per liter (mcmol/L)
Standard Deviation 11.165
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1
Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7)
|
0.93 micromole per liter (mcmol/L)
Standard Deviation 19.627
|
8.40 micromole per liter (mcmol/L)
Standard Deviation 30.876
|
7.20 micromole per liter (mcmol/L)
Standard Deviation 29.660
|
-4.50 micromole per liter (mcmol/L)
Standard Deviation 16.109
|
15.86 micromole per liter (mcmol/L)
Standard Deviation 24.024
|
1.40 micromole per liter (mcmol/L)
Standard Deviation 17.344
|
-4.43 micromole per liter (mcmol/L)
Standard Deviation 18.867
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 15, 22, 29 and 50Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=7 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=7 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=7 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=6 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2
Baseline (n =7, 5, 7, 7, 6)
|
281.14 mcmol/L
Standard Deviation 57.875
|
309.40 mcmol/L
Standard Deviation 47.600
|
301.14 mcmol/L
Standard Deviation 43.690
|
291.29 mcmol/L
Standard Deviation 37.911
|
303.67 mcmol/L
Standard Deviation 47.272
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2
Change at Day 8 (n =7, 5, 7, 6, 6)
|
-5.29 mcmol/L
Standard Deviation 19.678
|
-8.20 mcmol/L
Standard Deviation 11.100
|
-12.14 mcmol/L
Standard Deviation 12.668
|
-9.17 mcmol/L
Standard Deviation 23.043
|
-10.17 mcmol/L
Standard Deviation 21.720
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2
Change at Day 15 (n =7, 5, 7, 6, 6)
|
-1.86 mcmol/L
Standard Deviation 21.146
|
-8.20 mcmol/L
Standard Deviation 15.707
|
-39.29 mcmol/L
Standard Deviation 21.077
|
-11.67 mcmol/L
Standard Deviation 24.047
|
-14.67 mcmol/L
Standard Deviation 33.037
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2
Change at Day 22 (n =7, 5, 7, 6, 6)
|
-7.43 mcmol/L
Standard Deviation 13.176
|
-18.20 mcmol/L
Standard Deviation 20.462
|
-37.86 mcmol/L
Standard Deviation 19.945
|
-24.67 mcmol/L
Standard Deviation 20.925
|
-27.50 mcmol/L
Standard Deviation 25.399
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2
Change at Day 29 (n =7, 5, 7, 6, 4)
|
-4.43 mcmol/L
Standard Deviation 27.098
|
-26.60 mcmol/L
Standard Deviation 22.612
|
-37.57 mcmol/L
Standard Deviation 14.976
|
-32.67 mcmol/L
Standard Deviation 28.507
|
-41.00 mcmol/L
Standard Deviation 29.855
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2
Change at Day 50 (n =7, 5, 7, 7, 6)
|
-6.86 mcmol/L
Standard Deviation 20.732
|
-8.80 mcmol/L
Standard Deviation 14.446
|
-6.43 mcmol/L
Standard Deviation 20.871
|
-12.43 mcmol/L
Standard Deviation 26.732
|
-5.67 mcmol/L
Standard Deviation 31.258
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 15 and 29Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=15 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=6 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=6 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=7 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
n=5 Participants
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
n=7 Participants
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1
Baseline (n =15, 5, 6, 6, 7, 5, 7)
|
8.17 microgram per milliliter (mcg/mL)
Standard Deviation 5.021
|
5.02 microgram per milliliter (mcg/mL)
Standard Deviation 2.831
|
5.77 microgram per milliliter (mcg/mL)
Standard Deviation 1.306
|
5.35 microgram per milliliter (mcg/mL)
Standard Deviation 3.683
|
6.20 microgram per milliliter (mcg/mL)
Standard Deviation 5.440
|
12.04 microgram per milliliter (mcg/mL)
Standard Deviation 5.133
|
11.84 microgram per milliliter (mcg/mL)
Standard Deviation 8.122
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1
Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7)
|
0.39 microgram per milliliter (mcg/mL)
Standard Deviation 0.895
|
-0.36 microgram per milliliter (mcg/mL)
Standard Deviation 0.727
|
0.64 microgram per milliliter (mcg/mL)
Standard Deviation 0.639
|
0.15 microgram per milliliter (mcg/mL)
Standard Deviation 0.596
|
0.73 microgram per milliliter (mcg/mL)
Standard Deviation 0.632
|
0.00 microgram per milliliter (mcg/mL)
Standard Deviation 1.584
|
0.97 microgram per milliliter (mcg/mL)
Standard Deviation 0.629
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1
Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7)
|
0.38 microgram per milliliter (mcg/mL)
Standard Deviation 1.047
|
0.42 microgram per milliliter (mcg/mL)
Standard Deviation 1.711
|
1.50 microgram per milliliter (mcg/mL)
Standard Deviation 1.321
|
-0.32 microgram per milliliter (mcg/mL)
Standard Deviation 1.143
|
1.07 microgram per milliliter (mcg/mL)
Standard Deviation 1.111
|
0.32 microgram per milliliter (mcg/mL)
Standard Deviation 1.608
|
1.17 microgram per milliliter (mcg/mL)
Standard Deviation 0.780
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1
Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7)
|
0.46 microgram per milliliter (mcg/mL)
Standard Deviation 1.608
|
-0.36 microgram per milliliter (mcg/mL)
Standard Deviation 0.820
|
-0.52 microgram per milliliter (mcg/mL)
Standard Deviation 3.192
|
-0.62 microgram per milliliter (mcg/mL)
Standard Deviation 1.492
|
0.97 microgram per milliliter (mcg/mL)
Standard Deviation 1.467
|
0.36 microgram per milliliter (mcg/mL)
Standard Deviation 1.499
|
0.66 microgram per milliliter (mcg/mL)
Standard Deviation 1.110
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 15, 22, 29 and 50Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=7 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=7 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=7 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=6 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2
Baseline (n =7, 5, 7, 7, 6)
|
7.66 mcg/mL
Standard Deviation 4.351
|
6.32 mcg/mL
Standard Deviation 3.517
|
8.09 mcg/mL
Standard Deviation 6.240
|
7.59 mcg/mL
Standard Deviation 5.538
|
3.95 mcg/mL
Standard Deviation 1.291
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2
Change at Day 8 (n =7, 5, 7, 6, 6)
|
-0.10 mcg/mL
Standard Deviation 0.663
|
0.40 mcg/mL
Standard Deviation 0.962
|
0.41 mcg/mL
Standard Deviation 0.570
|
-0.08 mcg/mL
Standard Deviation 1.599
|
0.90 mcg/mL
Standard Deviation 0.502
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2
Change at Day 15 (n =7, 5, 7, 6, 6)
|
-0.03 mcg/mL
Standard Deviation 1.376
|
0.72 mcg/mL
Standard Deviation 1.512
|
1.21 mcg/mL
Standard Deviation 0.641
|
0.32 mcg/mL
Standard Deviation 2.483
|
0.63 mcg/mL
Standard Deviation 1.481
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2
Change at Day 22 (n =7, 5, 7, 6, 6)
|
0.13 mcg/mL
Standard Deviation 1.289
|
1.14 mcg/mL
Standard Deviation 0.518
|
1.73 mcg/mL
Standard Deviation 1.034
|
0.95 mcg/mL
Standard Deviation 3.086
|
1.28 mcg/mL
Standard Deviation 2.046
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2
Change at Day 29 (n =7, 5, 7, 6, 5)
|
0.36 mcg/mL
Standard Deviation 1.765
|
1.46 mcg/mL
Standard Deviation 0.730
|
1.83 mcg/mL
Standard Deviation 1.241
|
1.50 mcg/mL
Standard Deviation 2.900
|
1.60 mcg/mL
Standard Deviation 2.827
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2
Change at Day 50 (n =7, 5, 7, 7, 6)
|
0.40 mcg/mL
Standard Deviation 2.106
|
0.38 mcg/mL
Standard Deviation 2.381
|
-0.30 mcg/mL
Standard Deviation 1.294
|
1.64 mcg/mL
Standard Deviation 2.985
|
0.92 mcg/mL
Standard Deviation 2.076
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and 29Population: Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=5 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=6 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=6 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=7 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=5 Participants
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
n=7 Participants
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-Drug Antibodies (ADA): Stage 1
Day 29 (n =5, 5, 6, 6, 5, 7)
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Anti-Drug Antibodies (ADA): Stage 1
Day 1 (n =5, 6, 6, 7, 5, 7)
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, 29 and 50Population: Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Outcome measures
| Measure |
Stage 1: PF-04856883 Placebo
n=5 Participants
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=7 Participants
Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=7 Participants
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=6 Participants
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg
Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participant With Anti-Drug Antibodies (ADA): Stage 2
Day 1 (n =5, 7, 7, 6)
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participant With Anti-Drug Antibodies (ADA): Stage 2
Day 29 (n =5, 7, 6, 5)
|
0 participants
|
2 participants
|
2 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participant With Anti-Drug Antibodies (ADA): Stage 2
Day 50 (n =5, 7, 6, 6)
|
0 participants
|
3 participants
|
2 participants
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Stage 1: PF-04856883 Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Stage 1: PF-04856883 4 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Stage 1: PF-04856883 8 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 1: PF-04856883 12 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Stage 1: PF-04856883 18 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Stage 1: PF-04856883 24 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 1: PF-04856883 36 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Stage 2: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Stage 2: PF-04856883 12.0 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stage 1: PF-04856883 Placebo
n=15 participants at risk
Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 4 mg
n=5 participants at risk
Participants received PF-04856883 4 milligram (mg) subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 8 mg
n=6 participants at risk
Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 12 mg
n=6 participants at risk
Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 18 mg
n=7 participants at risk
Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 24 mg
n=5 participants at risk
Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 1: PF-04856883 36 mg
n=7 participants at risk
Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
|
Stage 2: Placebo
n=7 participants at risk
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12.0 mg
n=5 participants at risk
Participants received single dose of PF-04856883 12.0 mg subcutaneous injection on Day 1, 8, 15 and 22 in Stage 2.
|
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg
n=7 participants at risk
Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg
n=7 participants at risk
Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
n=6 participants at risk
Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7
|
20.0%
1/5
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7
|
0.00%
0/7
|
20.0%
1/5
|
28.6%
2/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
2/15
|
0.00%
0/5
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7
|
28.6%
2/7
|
20.0%
1/5
|
28.6%
2/7
|
28.6%
2/7
|
50.0%
3/6
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15
|
0.00%
0/5
|
0.00%
0/6
|
16.7%
1/6
|
42.9%
3/7
|
40.0%
2/5
|
28.6%
2/7
|
42.9%
3/7
|
40.0%
2/5
|
42.9%
3/7
|
57.1%
4/7
|
50.0%
3/6
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
42.9%
3/7
|
60.0%
3/5
|
42.9%
3/7
|
28.6%
2/7
|
40.0%
2/5
|
28.6%
2/7
|
42.9%
3/7
|
50.0%
3/6
|
|
General disorders
Asthenia
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
General disorders
Injection site reaction
|
6.7%
1/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
20.0%
1/5
|
0.00%
0/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15
|
20.0%
1/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7
|
0.00%
0/7
|
20.0%
1/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
28.6%
2/7
|
42.9%
3/7
|
40.0%
2/5
|
57.1%
4/7
|
42.9%
3/7
|
50.0%
3/6
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Vascular disorders
Hypertension
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Cardiac disorders
Palpitations
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Ear and labyrinth disorders
Ear pain
|
6.7%
1/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
20.0%
1/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
42.9%
3/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Gastrointestinal disorders
Faecal volume increased
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
20.0%
1/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
General disorders
Chest pain
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
20.0%
1/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
General disorders
Fatigue
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
20.0%
1/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
General disorders
Oedema peripheral
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
General disorders
Local swelling
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Infections and infestations
Gastroenteritis
|
6.7%
1/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Infections and infestations
Subcutaneous abscess
|
6.7%
1/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7
|
16.7%
1/6
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
6.7%
1/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
6.7%
1/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
6.7%
1/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Investigations
Blood uric acid increased
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Investigations
Heart rate increased
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7
|
80.0%
4/5
|
14.3%
1/7
|
0.00%
0/7
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
20.0%
1/5
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
6.7%
1/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
20.0%
1/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
6.7%
1/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
6.7%
1/15
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/6
|
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