NCT00386347已完成1 期
A Single Dose, Randomized, 5-Period, Balanced, Crossover Study to Assess the Relative Bioavailability of Three Formulations and Food Effect on GSK364735 and Pharmacokinetics Following a Double Blind, Placebo Controlled, Repeat Dose Administration to Healthy Subjects.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Part 1: PK parameters Day 1: AUC(0-t), AUC(0-t), Cmax, and C12 and C24 Part 2: PK parameters on Day 6: AUC(0-t), Ct, and Cmax
研究概览
简要总结
This study is a two-part study. Part one is designed to see how different formulations of GSK364735 are absorbed in the body and To see how food affects how GSK364735 is absorbed in the body. Part two is designed to see how repeat dosing affects how GSK364735 is absorbed in the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
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
- •The subject is healthy with no clinically significant problems identified by the physician.
- •Females of non-childbearing potential and males surgically sterile or agrees to birth control.
- •Body mass Index (BMI) of 19-29.9 (kg/m2).
排除标准
- •As a result of the physical examination, lab results the Investigator considers the subject unfit for the study.
- •Blood pressure and electrocardiogram is not normal
- •A history of alcohol or illicit drug abuse.
- •Tobacco use within 3 months.
- •Positive for Hepatitis B surface antigen, Hepatitis C antibody or HIV antibody.
- •Current use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements.
- •Has participated in a clinical trial within 30 days prior to the first dose of study medication.
- •Donated a pint of blood within a 56 day period.
- •History of allergy to study drug.
结局指标
主要结局
Part 1: PK parameters Day 1: AUC(0-t), AUC(0-t), Cmax, and C12 and C24 Part 2: PK parameters on Day 6: AUC(0-t), Ct, and Cmax
次要结局
- Part 1 and 2 safety measures: AE, Clinical labs, con meds, ECGs, and Vital signs Part 1: PK parameters Day 1: tmax, t1/2, tlag and CL/F Part 2: PK parameters Day 1&6: AUC 0-t, AUC 0-infinity, AUC 0-12, Cmax, C12 or C24, tmax, t1/2, CL/F, and tlag.
研究者
研究点 (1)
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