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临床试验/NCT01134718
NCT01134718已完成1 期

Pilot BA Study With Phase III/Commercial Versus Phase IIB Formulation. A Phase I, Open Label, Randomized, Single Dose, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of TMC435 Following Administration of Potential Phase III Formulations Compared to the Phase IIb Capsule

Tibotec Pharmaceuticals, Ireland0 个研究点目标入组 24 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
24
主要终点
Rate and extent of absorption of TMC435 following administration of 3 different capsule formulations under fed condition

研究概览

简要总结

The purpose of this study is to compare in healthy volunteers levels of TMC435 in the blood circulation after intake of 2 new capsule formulations with the level of TMC435 in the blood circulation after intake of the capsule formulation used in the Phase IIb studies.

详细描述

This is a randomized (study drug assigned by chance), open-label (all people involved know the treatment), single dose, crossover (volunteers will receive different treatments sequentially during the trial) study in healthy volunteers. The trial will evaluate the levels of TMC435 in the blood circulation after a single dose of 150 mg TMC435 administered as 3 different capsule formulations following breakfast. There will be a 7-day washout period between treatments and a 4-5 week follow-up at the end. Each volunteer will receive all three treatments. The main focus of the trial is the pharmacokinetic characteristics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of the different formulations. This evaluation requires multiple blood samples from Day 1 through 72 hours after dosing. Safety assessments (lab work, blood pressure, pulse and electrocardiogram) will follow a different schedule and are measured on Day -1 (day prior to taking first dose of drug), Day 1 (without lab work) and Day 4 of each treatment period, and 1 and 4-5 weeks after the last treatment. Each volunteer will receive 3 treatments, 7 days apart from each other. Each treatment consists of one single oral dose of 150 mg TMC435.

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
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

入选标准

  • Non-smoker for at least 3 months
  • Body Mass Index of 18.0 to 30.0 kg/m2
  • Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram

排除标准

  • Infection with Hepatitis A, B or C virus
  • Infection with the human immunodeficiency virus (HIV)
  • History of, or any current medical condition which could impact the safety of the participant in the study

研究组 & 干预措施

001

Experimental

TMC435 (F021) one morning dose of 150 mg

干预措施: TMC435 (F021) (Drug)

002

Experimental

TMC435 (G006) one morning dose of 150 mg

干预措施: TMC435 (G006) (Drug)

003

Experimental

TMC435 (G007) one morning dose of 150 mg

干预措施: TMC435 (G007) (Drug)

结局指标

主要结局

Rate and extent of absorption of TMC435 following administration of 3 different capsule formulations under fed condition

时间窗: Measured over a period of 4 consecutive days (Day1-Day4) per treatment. Treatments (3) are 7 days apart from each other. During 1st day of each treatment, 10 blood samples for determination of pharmacokinetic characteristics are taken.

次要结局

  • All reported Adverse Events + percentage of subjects who experienced at least 1 occurrence of a given event as a measure of Safety and Tolerability following administration of single doses of 150 mg TMC435(Till last follow up safety visit 4-5 weeks after last intake of study medication)

研究者

发起方
Tibotec Pharmaceuticals, Ireland
申办方类型
Industry
责任方
Sponsor

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