NCT01468714已完成1 期
A Phase I, Open-Label, Fixed Sequence Study To Estimate The Steady-State Effect Of Ketoconazole On The Single-Dose Pharmacokinetics Of PF-04937319 In Healthy Adult Subjects
适应症
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
- 10
- 试验地点
- 1
- 主要终点
- Cmax of PF-04937319
研究概览
简要总结
This study will evaluate the potential for a drug-drug interaction of PF-04937319 with ketoconazole, a potent inhibitor of the drug metabolizing enzyme CYP3A.
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
- None
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 or clinical laboratory tests.
- •Body Mass Index (BMI) of 17.5 to 29.9 kg/m2; and a total body weight >=50 kg (110 lbs).
- •Subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28-days after the last dose of treatment.
排除标准
- •Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
- •Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception
- •Consumption of grapefruit-containing products within 7 days prior to the first dose of study medication and while in the study protocol from at least 14 days prior to the first dose of study medication and for at least 28 days after the last dose of study medication
结局指标
主要结局
Cmax of PF-04937319
时间窗: Day 1 & Day 6
Tmax of PF-04937319
时间窗: Day 1 & Day 6
AUClast of PF-04937319
时间窗: Day 1 & Day 6
(as data permits) AUCinf of PF-04937319
时间窗: Day 1 & Day 6
(as data permits) t1/2 of PF-04937319
时间窗: Day 1 & Day 6
Cmax of PF-04937319 M1 metabolite
时间窗: Day 1 & Day 6
Tmax of PF-04937319 M1 metabolite
时间窗: Day 1 & Day 6
AUClast of PF-04937319 M1 metabolite
时间窗: Day 1 & Day 6
(as data permits) AUCinf of PF-04937319 M1 metabolite
时间窗: Day 1 & Day 6
(as data permits) t1/2 of PF-04937319 M1 metabolite
时间窗: Day 1 & Day 6
次要结局
- Urinary recovery of PF-04937319 M1 metabolite(Day 1)
- (as data permits) renal clearance (CLr) of PF-04937319 M1 metabolite(Day 1)
研究者
研究点 (1)
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