A Phase 1, Placebo-Controlled, Randomized Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenous Doses Of PF-05231023 In Obese Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
This is a trial in obese subjects to study the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-05231023.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects of non-childbearing potential between the ages of 21 and
- •Subjects with a BMI of 30 to 45.4 kg/m2 and total body weight >110 lbs.
排除标准
- •Recent (6 months) unstable concurrent disease.
- •History of allergic disease or drug allergies.
- •Any condition affecting food consumption or absorption.
研究组 & 干预措施
Placebo
干预措施: Placebo (Other)
100 mg PF-05231023
干预措施: 100 mg PF-05231023 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Day -7 through the last follow-up (Day 68)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were also reported for the 7-day pre-randomization period.
Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern
时间窗: Days -7 up to the last follow-up (Day 68)
Vital signs included supine systolic blood pressure, diastolic blood pressure and pulse rate. Vital signs criteria of potential clinical concern were 1), blood pressure: systolic greater than or equal to (\>=)30 millimeters of mercury (mm Hg) change from baseline in the same posture or systolic less than (\<)90 mm Hg; diastolic \>=20 mm Hg change from baseline in the same posture or diastolic \<50 mm Hg; 2), Pulse rate: supine/Sitting: \<40 or greater than (\>) 120 beats per minute (bpm); Standing: \<40 or \>140 bpm.
Number of Participants With Electrocardiogram (ECG) Data Met Criteria of Potential Clinical Concern
时间窗: Days -7 up to the last follow-up (Day 68)
ECG criteria of potential clinical concern were 1), PR interval:\>=300 msec, \>=25% increase when baseline \>200 msec, or \>=50% increase when baseline \<=200 msec; 2), QRS interval:\>=140 msec, or \>=50% increase from baseline; 3), QT interval corrected for heart rate (QTc)/QTc interval using Fridericia's formula (QTcF):\>=500 msec, QTcF interval: absolute value \>=450 - \<480 msec(borderline), \>=480 msec (prolonged), absolute change 30 - \<60 msec (borderline) or \>=60 msec (prolonged). 12-lead ECG (triplicate) was performed on Day 0 and 12-lead ECG (singlet) was performed at other times.
Number of Participants With Positive Anti-PF-05231023 Antibodies and Neutralizing Antibodies.
时间窗: Days 1 up to the last follow-up (Day 68)
Anti-PF-05231023 antibodies were analyzed using a tiered testing strategy of screen, confirm, and titer characterization. Positive was defined as titer value \>=6.23 and negative was defined as titer value \<6.23. Samples tested positive were also to be analyzed in a neutralization assay to determine whether or not they were neutralizing or non-neutralizing.
次要结局
- Number of Participants With Abnormal Clinical Laboratory Measurements(Days -7 up to the last follow-up (Day 68))
- Area Under the Concentration Versus Time Curve From Time 0 to Tau, the Dosing Interval (AUCtau) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)(Days 1 and 25)
- Maximum Plasma Concentration (Cmax) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)(Days 1 and 25)
- Lowest Concentration Observed During Dosing Interval (Cmin) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)(Day 25)
- Average Concentration at Steady State (Cav) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)(Day 25)
- Time for Cmax (Tmax)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)(Day 25)
- Clearance (CL)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)(Day 25)
- Terminal Elimination Half-life (t1/2)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)(Day 25)
- Observed Accumulation Ratio (Rac) for Cmax and AUCtau of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)(Day 25)