TMC435-TiDP16-C117: The Effect of TMC435 on the Results of Electrocardiograms (Electric Recording of the Heart) in Healthy Volunteers
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of TMC435 on the results of
      electrocardiograms (ECGs) in healthy volunteers. An electrocardiogram is an electric
      recording of the heart. TMC435 is being investigated for the treatment of chronic hepatitis C
      virus infection.
    

Detailed description: 
      This is a double-blind, double-dummy, randomized, 4-period cross-over, placebo- and
      positive-controlled, Phase I study. This means neither the study doctor nor the participants
      know in which treatment session you will receive which active medication or matching placebo.
      Every participant will receive 4 treatment sessions (Treatments A, B, C and D) in a different
      order. The order in which you receive the treatment sessions is determined by chance, like
      tossing a coin. The purpose of the study is to evaluate the effect of TMC435 on the results
      of electrocardiograms (electric recording of the heart). Two dose regimens of TMC435 will be
      tested, ie, 150 mg once daily (the dose that will be given to patients) and 350 mg once daily
      (a dose higher than the one that will be given to patients), administered for 7 days. A
      single dose of 400 mg moxifloxacin will be used as a positive control to assess trial
      sensitivity. The trial population will consist of 60 healthy volunteers of which
      approximately 18 will be females. In each treatment, dummy capsules will be added in order to
      have the same number of capsules in each treatment. Treatment A will consist of 150 mg TMC435
      once daily for 7 days (2 capsules of TMC435 and 2 capsules placebo on days 1-7, 1 placebo
      tablet for moxifloxacin on Day 7). Treatment B will consist of 350 mg TMC435 once daily for 7
      days (4 capsules of TMC435 on Days 1-7, 1 placebo tablet for moxifloxacin on Day 7).
      Treatment C will consist of 400 mg moxifloxacin on Day 7 (4 capsules of placebo for TMC435 on
      Days 1-7, 1 moxifloxacin tablet on Day 7). In Treatment D only placebo will be given (4
      capsules of placebo for TMC435 on Days 1-7, 1 placebo tablet for moxifloxacin on Day 7).
      There will be a washout period of at least 10 days between subsequent treatments. A
      pharmacogenomic blood sample (DNA sample, blood sample from which your genetic information
      can be analyzed) will be collected from all volunteers and will be analyzed upon observation
      of irregular electrocardiogram during the study. The purpose is to see if irregularities in
      the electrocardiogram can be linked to genetic variants. DNA samples may also be analyzed for
      additional genes related to pharmacokinetics (what the body does with the drug),
      pharmacodynamics (what the drug does to your body) or safety and tolerability of TMC435
      during the study, as necessary. Two oral doses of TMC435 (150 or 350 mg) or placebo will be
      given once daily for 7 consecutive days. A single dose of moxifloxacin 400 mg will be
      administered orally on Day 7 in one of the treatment sessions only.
    

Intervention name(s): TMC435; Placebo for TMC435; TMC435; Placebo for TMC435; Moxifloxacin; Placebo for moxifloxacin; Placebo for TMC435
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 2 capsules of 75 mg once daily for 7 days in Treatment A; 4 placebo capsules once daily for 7 days in Treatment C; 2 capsules of 75 mg and 2 capsules of 100 mg once daily for 7 days in Treatment B; 2 placebo capsules once daily for 7 days in Treatment A; 1 tablet of 400 mg on Day 7 of Treatment C; 1 placebo tablet on Day 7 of Treatments A, B and D; 4 placebo capsules once daily for 7 days in Treatment D
Intervention MeSH terms: Moxifloxacin; Simeprevir; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis C; TMC435-TiDP16-C117; TMC435-C117; TMC435; HCV; Moxifloxacin; ECG; QT; QTc