A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability, Pharmacokinetics And Effect On Midazolam Pharmacokinetics Of Multiple Oral Doses Of PF-05175157 In Otherwise Healthy Overweight And Obese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- fasting triglycerides
研究概览
简要总结
This study is designed to assess the safety, tolerability and pharmacokinetics of multiple oral 200-mg doses of Pf-05175157 administered twice daily for 14 days in healthy overweight and obese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (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).
- •Body Mass Index (BMI) of 25 to 35 kg/m2 inclusive; and a total body weight >50 kg (110 lbs).
- •Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
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).
- •Evidence or history of any chronic ongoing or current pulmonary disease.
- •History of smoking in the past 5 years and a history of smoking more than 10 pack years, or history or evidence of habitual use of other (non smoked) tobacco or nicotine containing products. Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
研究组 & 干预措施
Arm Label Pf-05175157, placebo, midazolam
干预措施: Pf-05175157 (Drug)
Arm Label Pf-05175157, placebo, midazolam
干预措施: placebo (Drug)
Arm Label Pf-05175157, placebo, midazolam
干预措施: midazolam (Drug)
结局指标
主要结局
fasting triglycerides
时间窗: 14 days
fasting LDL-cholesterol
时间窗: 14 days
Ae,tau
时间窗: 0-12 hr
fasting total cholesterol
时间窗: 14 days
Ae%
时间窗: 0-12 hr
Clr
时间窗: 0-12 hr
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
Maximum Observed Plasma Concentration (Cmax)
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
Plasma Decay Half-Life (t1/2)
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
Apparent Volume of Distribution (Vz/F)
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
Apparent Oral Clearance (CL/F)
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
Accumulation Ratio (Rac)
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours postdose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
fasting HDL cholesterol
时间窗: 14 days
次要结局
未报告次要终点