TMC435-TiDP16-C113: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of TMC435
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      This is a Phase I, open-label trial to investigate the pharmacokinetics (how the drug is
      absorbed into the bloodstream, distributed in the body and eliminated from the body) of
      TMC435 in 8 participants with moderate hepatic impairment and 8 participants with severe
      hepatic impairment as compared to 8 participants with normal hepatic function, matched for
      age, gender, race, BMI (body mass index = weight in kilogram divided by square of height in
      meters) and smoking status. Open-label means that the study doctor and the participants know
      what treatment will be assigned to them. All participants will receive 150 mg of TMC435 by
      mouth for 7 days. Participants with severe hepatic impairment will be treated when the
      pharmacokinetic profiles of TMC435 in participants with moderate hepatic impairment have been
      evaluated. The dose of TMC435 may be changed for participants with severe hepatic impairment
      after evaluation of the blood levels TMC435 in participants with moderately impaired hepatic
      function. Tolerability and safety of TMC435 will be assessed throughout the trial period.
      Illnesses and side effects will be checked at every visit. Blood samples will be taken at
      screening, on the day before TMC435 intake, on days 2, 3, 5, 6, 7 (11 times), 8 and 9 and at
      2 follow-up visits. Blood levels of TMC435 will be determined on days 2, 5, 6, 7, 8 and 9.
      Urine samples, ECG and vital signs will be taken at screening, twice on day 7 and at 2
      follow-up visits. A physical examination will be done at screening, on the day before TMC435
      intake, on day 9 and at both follow-up visits. All participants will receive a 150 mg dose of
      TMC435 for 7 days, given by mouth as 2 capsules of 75 mg. After evaluation of the
      pharmacokinetic profiles of TMC435 in participants with moderate hepatic impairment, the dose
      may be changed for participants with severe hepatic impairment.
    

Intervention name(s): TMC435
Intervention type(s): Drug
Intervention description(s): 150 mg (two 75-mg capsules) orally (by mouth) once daily for 7 days
Intervention MeSH terms: Simeprevir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TMC435-TiDP16-C113; TMC435-C113; TMC435; HCV; Protease Inhibitor; Hepatitis C