drugset / Trial / NCT01046058
TMC435-TiDP16-C113: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of TMC435
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Simeprevir | Small molecule | 150 mg | Oral |