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drugset / Trial / NCT01707342

A Study to Assess the Absolute Bioavailability and Pharmacokinetics of Simeprevir (TMC435) Administered as Single Oral Doses of TMC435 and an Intravenous Microdose of [3H]-TMC435 in Healthy Male Patients

NCT01707342 ↗

Phase 1 Completed 6 enrolled Janssen R&D Ireland
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the absolute bioavailability and pharmacokinetics (what the body does to the medication) of simeprevir (TMC435) after administration of single oral doses of 50 mg and 150 mg when administered together with a single intravenous (IV) dose of 100 microgram \[3H\]-TMC435 in healthy male participants.

Timeline

Start
2012-10
Primary completion
2012-11
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Simeprevir Small molecule 100 ug Oral
Subject Simeprevir Small molecule 50 mg Oral
Subject Simeprevir Small molecule 150 mg Oral

Indications

No indication recorded.