NCT01707342View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2012

Conditions
Healthy Male Participants
Interventions
DRUG

Simeprevir (TMC435)

Treatment A: Simeprevir (TMC435) 50 mg; and Treatment B: Simeprevir (TMC435) 150 mg; will be followed 5 hours later by a single 10 minute intravenous infusion of \[3H\]-TMC435 (100 microcurie) 100 microgram in Period 1 and Period 2, respectively.

Trial Locations (1)

Unknown

Merksem

All Listed Sponsors
lead

Janssen R&D Ireland

INDUSTRY

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 | Biotech Hunter | Biotech Hunter