drugset / Trial / NCT01224197

TMC435 HPC1004 - Phase I Study Investigating the Pharmacokinetics of TMC435 in Healthy Chinese Volunteers

NCT01224197

Phase 1 Completed 32 enrolled Tibotec Pharmaceuticals, Ireland
RandomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the pharmacokinetics, safety and tolerability of single and multiple oral doses of TMC435 in Chinese healthy volunteers. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.

Timeline

Start
2010-10
Primary completion
2011-01
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Simeprevir Small molecule 100 mg Oral
Subject Simeprevir Small molecule 200 mg Oral