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
Condition: Healthy Male Participants
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), sequential (a
      single group of participants where study medication is administered in a sequence),
      single-dose study to assess the absolute bioavailability and pharmacokinetics (what the body
      does to the medication) of single oral doses of 50 mg and 150 mg simeprevir (TMC435)
      administered together with an intravenous (IV) microdose of 100 microgram [3H]-TMC435 in
      healthy male participants. The study consists of 3 phases, screening phase (21 days prior to
      administration of study medication), treatment phase, and a follow up phase. In the treatment
      phase, participants will receive 2 treatments, ie, Treatment A: single oral dose of
      simeprevir (TMC435) 50 mg followed 5 hours later by a single 10 minute IV infusion of
      [3H]-TMC435 (100 microcurie) 100 microgram; and Treatment B: single oral dose of simeprevir
      (TMC435) 150 mg followed 5 hours later by a single 10 minute IV infusion of [3H]-TMC435 (100
      microcurie) 100 microgram. Treatments will be administered in two consecutive treatment
      periods, first Treatment A in Period 1, followed by Treatment B in Period 2; separated by a
      washout period (period when the participant is not receiving any study medication) of 7 to 14
      days. The follow up will be for 5 to 7 days after end of Period 2. Blood samples will be
      collected for full plasma pharmacokinetics evaluations; along with urine and stool samples
      for analysis of total plasma radioactivity. Safety evaluations for adverse events, clinical
      laboratory tests, electrocardiogram, vital signs, physical examination, liver volume
      determination, and specific toxicities will be monitored throughout the study. The total
      duration of the study will be approximately 42 days.
    

Intervention name(s): Simeprevir (TMC435)
Intervention type(s): Drug
Intervention description(s): 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.
Intervention MeSH terms: Simeprevir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy male participants; Absolute bioavailability; Bioavailability; Pharmacokinetics; Simeprevir; TMC435; [3H]-TMC435; Hepatitis C virus; HCV