drugset / Trial / NCT01046058

TMC435-TiDP16-C113: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of TMC435

NCT01046058

Phase 1 Completed 23 enrolled Tibotec Pharmaceuticals, Ireland
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to investigate the effect of moderate and severe hepatic impairment on the pharmacokinetics of TMC435. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. In addition, the short-term safety and tolerability of TMC435 in participants with hepatic impairment will be determined. The results of this study will guide dose recommendations for TMC435 in patients with impaired liver function.

Timeline

Start
2010-01
Primary completion
2011-07
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Simeprevir Small molecule 150 mg Oral