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

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.

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Key information

Conditions

Hepatitis C Virus Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TMC435

Drug

Primary outcomes

Rate and extent of absorption of TMC435 following administration of the tablet vs the capsule formulations and rate and extent of absorption of TMC435 following administration of the capsule formulation fasted or with food

Time frame: Measured over a period of 4 consecutive days (Day1-Day4) per treatment. Treatments (4) are 14 days apart from each other. During 1st day of each treatment, 10 blood samples for determination of pharmacokinetic characteristics are taken.

Secondary outcomes

Safety and tolerability following administration of single doses of 150 mg TMC435

Time frame: AEs: continuously: laboratory, vital signs and ECG parameters: 3 visits per treatment, for 4 treatment periods

Sponsors and collaborators

Lead sponsor

Tibotec Pharmaceuticals, Ireland

Industry

Registry information

Official study title

A Phase I Study in Healthy Subjects to Assess the Relative Bioavailability of TMC435 Following Administration of Potential Phase III Formulations Compared to the Phase IIb Capsule and to Assess the Effect of Food on the Bioavailability of TMC435 Following Intake of the Phase IIb Capsule

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Dec 1, 2009
Registry last updated: May 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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