A Phase I, Open-label Study to Evaluate the Relative Bioavailability of IDX184 and Food Effect in Healthy Male Subjects

Merck Sharp & Dohme LLC0 个研究点目标入组 12 人开始时间: 2011年4月最近更新: 2016年1月26日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 12
主要终点: Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to 24 hours (AUC 0-24)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to:

Assess the relative bioavailability of 2 oral formulations of samatasvir (capsule and tablet prototype test formulation)
Compare the amount of study drug that is in the blood after taking either the capsule form of the drug or the tablet form of the drug while fasting.
Determine the amount of study drug that is in the blood after eating a meal.
Evaluate the safety of the tablet form of samatasvir in healthy people.

详细描述

Each participant will receive each of the formulations in a crossover design. Part A Periods 1 and 2: Participants will receive either samatasvir capsules or tablets according to randomization under fasting conditions on Days 1 and 8. Part A Period 3: All participants will receive samatasvir tablets under fed conditons on Day 15.

Each dose will be separated by a 7-day wash-out period. Part B: All participants will receive samatasvir capsules under fed conditons on Day 1.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
盲法: None

入排标准

年龄范围: 19 Years 至 65 Years（Adult, Older Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Must be a healthy male with body mass index (BMI) between 18 and 35 kg/m
•Must agree to use an acceptable double-barrier method of birth control.
•Must provide written informed consent after the study has been fully explained.

排除标准

•History of clinically significant diseases, as determined by the investigator.
•Safety laboratory abnormalities at screening which are clinically significant.
•Positive screening test for hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV).
•Use of chronic prescription medications within 3 months, acute prescription medications within 14 days, or systemic over-the-counter (OTC) medications within 7 days of the starting the study.
•Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years.

研究组 & 干预措施

Part A: Samatasvir cap→tab→tab; Part B: cap

Active Comparator

Part A: Samatasvir capsule as a single dose on Day 1 (fasting state) followed by samatasvir tablet as a single dose on Day 8 (fasting state) followed by samatasvir tablet as a single dose on Day 15 (fed state); Part B: samatasvir capsule as a single dose on Day 1 (fed state)

干预措施: Samatasvir tablet (Drug)

Part A: Samatasvir cap→tab→tab; Part B: cap

Active Comparator

干预措施: Samatasvir capsule (Drug)

Part A: Samatasvir tab→cap→tab; Part B: cap

Active Comparator

Part A: Samatasvir tablet as a single dose on Day 1 (fasting state) followed by samatasvir capsule as a single dose on Day 8 (fasting state) followed by samatasvir tablet as a single dose on Day 15 (fed state); Part B: samatasvir capsule as a single dose on Day 1 (fed state)

干预措施: Samatasvir tablet (Drug)

Part A: Samatasvir tab→cap→tab; Part B: cap

Active Comparator

干预措施: Samatasvir capsule (Drug)

结局指标

主要结局

Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to 24 hours (AUC 0-24)

时间窗: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours

Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to infinity (AUC 0-infinity)