NCT01146327已完成1 期
A Phase 1, Parallel, Randomized Trial To Assess The Effect Of Time Of Dosing On The Pharmacodynamics, Pharmacokinetics, Safety And Tolerability Of Multiple Oral Doses Of PF-04620110 In Otherwise Healthy Overweight Or Obese Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate additional pharmacodynamic markers in response to multiple oral doses of PF-04620110.
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, 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
Experimental
干预措施: PF-04620110 (Drug)
Placebo Comparator
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate additional pharmacodynamic markers in response to multiple oral doses of PF-04620110.
时间窗: Day 1 to Day 13
To evaluate secondary Pharmacodynamic Endpoints in response to a liquid meal test in response to multiple oral doses of PF-04620110.
时间窗: Day 6 and Day 14
次要结局
- To characterize the PK of PF-04620110 following multiple oral doses in otherwise healthy overweight and obese subjects.(Baseline to 2 weeks)
- To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, and clinical safety laboratory measurements.(Baseline to 2 weeks)
研究者
研究点 (1)
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