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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hepatitis C Virus

Intervention / Treatment
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* Drug: TMC435 (G006)
* Drug: TMC435 (F021)
* Drug: TMC435 (G007)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 001<br>TMC435 (F021) one morning dose of 150 mg | Drug: TMC435 (F021)<br>* one morning dose of 150 mg<br>|
| Experimental: 002<br>TMC435 (G006) one morning dose of 150 mg | Drug: TMC435 (G006)<br>* one morning dose of 150 mg<br>|
| Experimental: 003<br>TMC435 (G007) one morning dose of 150 mg | Drug: TMC435 (G007)<br>* one morning dose of 150 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate and extent of absorption of TMC435 following administration of 3 different capsule formulations under fed condition |  | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TMC435-TiDP16-C119, TMC435-C119, TMC435, Protease inhibitor, HCV, Hepatitis C, Bioavailability