A Phase 1 Placebo-Controlled Study To Assess Safety, Tolerability, Pharmacokinetics And Effect On Midazolam Pharmacokinetics Of Multiple Oral Doses Of PF-05175157 Administered In A Tablet Formulation 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
- 15
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma PF-05175157 Concentration (Cmax)
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
- 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
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •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).
- •Women must be of non childbearing potential.
- •Body Mass Index (BMI) of 25 to 35 kg/m2 inclusive; and a total body weight >50 kg (110 lbs).
- •An informed consent document signed and dated by the subject.
- •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
PF-05175157, Midazolam
Day 0: Midazolam 2 mg administered alone Days 1-14: 200 mg PF-05175157 administered BID Day 11: Midazolam and PF-05175157
干预措施: PF-05175157 (Drug)
PF-05175157, Midazolam
Day 0: Midazolam 2 mg administered alone Days 1-14: 200 mg PF-05175157 administered BID Day 11: Midazolam and PF-05175157
干预措施: Midazolam (Drug)
Placebo, Midazolam
Day 0: Midazolam 2 mg administered alone Days 1-14: Placebo administered BID Day 11: Midazolam and Placebo
干预措施: Placebo (Other)
Placebo, Midazolam
Day 0: Midazolam 2 mg administered alone Days 1-14: Placebo administered BID Day 11: Midazolam and Placebo
干预措施: Midazolam (Drug)
结局指标
主要结局
Maximum Observed Plasma PF-05175157 Concentration (Cmax)
时间窗: 0 - 48 hours postdose
Steady State
Area Under the Curve from Time Zero to end of dosing interval for PF-05175157 (AUCtau)
时间窗: 0 - 10 hrs postdose
Single Dose
Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax)
时间窗: 0 - 48 hours postdose
Steady State
Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-05175157
时间窗: 0 - 48 hours postdose
Steady State
Apparent Oral Clearance of PF-05175157 (CL/F)
时间窗: 0 - 48 hours postdose
Accumulation Ratio of PF-05175157 (Rac)
时间窗: 0 - 10 hours postdose
Plasma Decay Half-Life of PF-05175157 (t1/2)
时间窗: 0 - 48 hours postdose
Apparent Volume of Distribution of PF-05175157 (Vz/F)
时间窗: 0 - 48 hours postdose
Urinary Recovery for PF-05175157 (AE24)
时间窗: 0 - 24 hours postdose
Amount of PF-05175157 recovered in urine over 24 hours
Renal Clearance for PF-05175157 (CLr)
时间窗: 0 - 24 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time for midazolam [AUC (0 - inf)]
时间窗: 0 - 48 hours postdose
Area Under the Curve From Time Zero to Last Quantifiable Concentration for midazolam [AUC (0-t)]
时间窗: 0 - 48 hours postdose
Maximum Observed Plasma Concentration for midazolam (Cmax)
时间窗: 0 - 48 hours postdose
Time to Reach Maximum Observed Plasma midazolam Concentration (Tmax)
时间窗: 0 - 48 hours post dose
Plasma Decay Half-Life of midazolam (t1/2)
时间窗: 0 - 48 hours postdose
Fasting triglycerides
时间窗: 14 days
Total cholesterol
时间窗: 14 days
LDL cholesterol
时间窗: 14 days
HDL cholesterol
时间窗: 14 days
次要结局
未报告次要终点