A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability And Pharmacokinetics Of Pf-05161704 After Administration Of Multiple Escalating Oral Doses In Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pharmacokinetic Endpoints: single dose and steady state pharmacokinetics of PF-05161704 and its metabolite PF-05200145. Urinary recovery will also be assessed for PF-05161704 and PF-05200145
研究概览
简要总结
The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple escalating oral doses of PF-05161704 in healthy volunteers
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive
- •Body Mass Index (BMI) of 24.5 to 35.5 kg/m2 and a total body weight >50 kg (110 lbs.)
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •Any condition possibly affecting drug absorption (e.g., gastrectomy).
- •History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- •History or evidence of habitual use of tobacco or nicotine containing products within 3 months of screening or positive cotinine test at screening or Day -1.
研究组 & 干预措施
5 mg PF-05161704 or Placebo
干预措施: PF-05161704 or Placebo (Drug)
15 mg PF-05161704 or Placebo
Planned dose: may be modified based on emerging PK and safety data.
干预措施: PF-05161704 or Placebo (Drug)
50 mg PF-05161704 or Placebo
Planned dose: may be modified based on emerging PK and safety data.
干预措施: PF-05161704 or Placebo (Drug)
150 mg PF-05161704 or Placebo
Planned dose: may be modified based on emerging PK and safety data.
干预措施: PF-05161704 or Placebo (Drug)
xx mg PF-05161704 or Placebo
Planned dose and dosing regimen will be determined based on emerging PK and safety data.
干预措施: PF-05161704 or Placebo (Drug)
xxx mg PF-05161704 or Placebo
Dose will be determined based on data from previous 5 arms.
干预措施: PF-05161704 or Placebo (Drug)
yy mg PF-05161704 or Placebo
Dose will be determined based on data from previous 6 arms
干预措施: PF-05161704 or Placebo (Drug)
yyy mg PF-05161704 or Placebo
Dose will be determined based on data from previous 7 arms.
干预措施: PF-05161704 or Placebo (Drug)
结局指标
主要结局
Pharmacokinetic Endpoints: single dose and steady state pharmacokinetics of PF-05161704 and its metabolite PF-05200145. Urinary recovery will also be assessed for PF-05161704 and PF-05200145
时间窗: 2 weeks
Safety and tolerability endpoints evaluated by adverse event monitoring, laboratory values, cardiovascular monitoring
时间窗: 2 weeks
次要结局
- Exploratory Parameters: absolute value and change from Day 0 baseline in concentrations of fasting serum lipids and body weight(2 weeks)
- Pharmacodynamic Endpoints: Absolute value and change from Day 0 baseline in postprandial GLP-1. Postprandial plasma PYY, triglycerides and apoB48. Absolute value and change from baseline in apoB100 and VLDL(2 weeks)