drugset / Trial / NCT01689623

A Pharmacokinetic Interaction Study Between TMC435, Atorvastatin and Simvastatin in Healthy Participants

NCT01689623

Phase 1 Completed 36 enrolled Janssen Research & Development, LLC
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate effects of steady-state concentrations (constant concentration of medication in the blood) of TMC435 on the single dose pharmacokinetics (what the body does to the medication) of atorvastatin, the active metabolites ortho- and parahydroxylated atorvastatin, simvastatin and the active metabolite simvastatin acid. Plasma hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitory activity after a single dose of atorvastatin or simvastatin, either alone or in combination with TMC435 will be also evaluated.

Timeline

Start
2012-06
Primary completion
2012-08
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 40 mg Oral
Subject Simeprevir Small molecule 150 mg Oral
Subject Simvastatin Small molecule 40 mg Oral

Indications

No indication recorded.