A Phase 1 Placebo-Controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Multiple Escalating Oral Doses Of PF-04620110 In Otherwise Healthy Overweight And Obese Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, andc linical safety laboratory measurements.
研究概览
简要总结
PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics, of multiple oral doses of PF-04620110.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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 subjects between the ages of 18 and 55 years
- •Body Mass Index (BMI) of 26.5 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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
研究组 & 干预措施
PF-04620110
干预措施: PF-04620110 (Drug)
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, andc linical safety laboratory measurements.
时间窗: Baseline to 2 weeks
To characterize the PK of PF-04620110 following multiple oral doses in otherwise healthy overweight and obese subjects.
时间窗: Baseline to 2 weeks
To characterize the effect of PF-04620110 on postprandial lipid metabolism measures.
时间窗: Baseline to 2 weeks
次要结局
- Triglyceride excursions(Day -1, Day 1, and Day 14)
- Glucose, insulin, and C-peptide excursions(Day -1 and Day 14)
- Gut hormone excursions- including active GLP-1, total amide GLP-1, ghrelin, GIP, and PYY(Day -1 and Day 14)
- To examine additional pharmacodynamic markers in response to multiple oral doses of PF-04620110.(Day -1 and Day 14)
- Secondary Pharmacodynamic Endpoints in response to a liquid meal test(Day -1 and Day 14)
- Additional Secondary Pharmacodynamic Endpoint: Fasting adiponectin(Day -1 and Day 14)