drugset / Trial / NCT01022125

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

NCT01022125

Phase 1 Completed 28 enrolled Tibotec Pharmaceuticals, Ireland
RandomizedCrossoverOpen-labelTreatment

Summary

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.

Timeline

Start
2010-01
Primary completion
2010-04
Completion
2010-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Simeprevir Small molecule 150 mg