NCT01134718

TMC435-TiDP16-C119 - A Study Comparing 2 New Capsule Formulations of TMC435 to an Established Capsule Formulation and Evaluating the Respective Blood Levels of TMC435 Following Single Dose Administration

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Tibotec Pharmaceuticals, Ireland · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatitis C Virus

Interventions

Type	Name	Description
DRUG	TMC435 (G006)	one morning dose of 150 mg
DRUG	TMC435 (F021)	one morning dose of 150 mg
DRUG	TMC435 (G007)	one morning dose of 150 mg

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2010-06-02
• Last updated: 2013-04-09