TMC435-TiDP16-C121: A Study Comparing 2 Tablet Formulations of TMC435 to an Established Capsule Formulation and Evaluating the Effect of Food on Blood Levels of TMC435

Tibotec Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Hepatitis C Virus

Treatments

Drug: TMC435

Study type

Interventional

Funder types

Industry

Identifiers

NCT01022125

CR016744

Details and patient eligibility

About

The purpose of this study is to compare the levels of TMC435 in the blood circulation after intake of 2 tablet formulations with the level of TMC435 in the blood circulation after intake of a capsule formulation. The trial will also evaluate levels of TMC435 in the blood circulation after intake of the capsule formulation fasted or following a meal.

Full description

This is a randomized (study drug assigned by chance), open-label (all people involved know the identity of the intervention), single dose, crossover (volunteers will receive different interventions 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 as a capsule formulation taken fasted (Treatment A) and following a meal (Treatment B). In addition, the study will evaluate the levels of TMC435 in the blood circulation after intake of a single dose of 150 mg TMC435 as 2 different tablet formulations (Treatments C and D). There will be a 14-day washout period between treatments and a 4-5 week follow-up at the end. Each volunteer will receive all four 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 (day of first dosing) and/or Day 4 of each treatment period, and 4 weeks after the last treatment. Each volunteer will receive 4 treatments, about 14 days apart from each other. Each treatment consists of one single dose of 150 mg TMC435.

Enrollment

28 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)
Women who are pregnant or breastfeeding
History of, or any current medical condition which could impact the safety of the participant in the study