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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Simeprevir

Criteria

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