NCT01537497已完成1 期
Phase 1 Four-Arm Parallel Group, Placebo-Controlled Study To Evaluate The Effects Of Single Doses Of PF- 05175157 At Three Dose Levels On Pharmacodynamic And Metabolic Parameters In Healthy Volunteers
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
- 31
- 试验地点
- 1
- 主要终点
- Modulation of carbohydrate and lipid metabolism
研究概览
简要总结
The primary purpose of this study is to evaluate pharmacodynamics of single oral doses of PF-05175157 in a dose-dependent fashion 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 subjects between the ages of 18 and 55 years, inclusive.
- •Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests. In addition, subjects must have normal pulmonary function tests and normal ocular findings.
- •Women must be of non-childbearing potential.
- •Body Mass Index (BMI) of 19.5 35.5 kg/m2, and a total body weight of > 50 kg (110 lbs).
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and seasonal allergies at time of dosing).
- •Evidence or history of any chronic ongoing or current pulmonary disease.
- •History of smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day -
- •Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
研究组 & 干预措施
100 mg PF-05175157
Experimental
The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.
干预措施: PF-05175157 (Drug)
250 mg PF-05175157
Experimental
The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.
干预措施: PF-05175157 (Drug)
600 mg PF-05175157
Experimental
The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.
干预措施: PF-05175157 (Drug)
Placebo
Placebo Comparator
The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.
干预措施: Placebo (Drug)
结局指标
主要结局
Modulation of carbohydrate and lipid metabolism
时间窗: 24 hours
次要结局
- Cmax of PF-05175157 after single oral doses(24 hours)
- Tmax of PF-05175157 after single oral doses(24 hours)
- Area under the curve (AUC) of PF-05175157 after single oral doses(24 hours)
研究者
研究点 (1)
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