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

Tibotec Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Hepatitis C Virus

Treatments: Drug: TMC435 (G006); Drug: TMC435 (F021); Drug: TMC435 (G007)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01134718

CR017155

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

001

Experimental group

Description:

TMC435 (F021) one morning dose of 150 mg

Treatment:

Drug: TMC435 (F021)

002

Experimental group

Description:

TMC435 (G006) one morning dose of 150 mg

Treatment:

Drug: TMC435 (G006)

003

Experimental group

Description:

TMC435 (G007) one morning dose of 150 mg

Treatment:

Drug: TMC435 (G007)