TMC207TBC1003 - A Study in Healthy Volunteers Investigating the Effect of Single-dose TMC207 on the QT/QTc Interval Under Fed Conditions
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of an 800-mg single dose of TMC207 on the
      QT/QTc interval in healthy volunteers.
    

Detailed description: 
      TMC207 is being investigated for the treatment of M. Tuberculosis (MTB, formerly known as
      TBC) infection. This study is designed to establish the effect of a single dose of TMC207 on
      the QT/QTc interval in healthy volunteers under fed conditions. This is a Phase I,
      double-blind (study doctor nor participants will know which treatment will be received),
      randomized (study medication is assigned by chance, like tossing a coin), placebo- and
      active-controlled study to evaluate the effect of single-dose TMC207 on the QT/QTc interval
      in healthy volunteers. A single dose of 400 mg moxifloxacin will be used as a positive
      control to assess trial sensitivity. The trial population will consist of 88 healthy
      volunteers. Forty-four participants will be randomized to Group 1, and 22 participants will
      be randomized to each of the Groups 2 and 3. Each gender should be represented by at least
      40%. Each participant will receive one of the Treatments A or B in one treatment session.
      Participants in Group 1 will take a single 800-mg dose of TMC207 on Day 1 and a single dose
      of moxifloxacin placebo on Day 2 (Treatment A). Participants in Groups 2 and 3 will take a
      single dose of TMC207 placebo on Day 1 and a single 400-mg dose of moxifloxacin on Day 2
      (Treatment B). All intakes of TMC207, moxifloxacin, TMC207 placebo and moxifloxacin placebo
      will be taken with standardized meals. The duration of the study will be 3 days, screening
      and follow-up period not included. On Days -1, 1, and 2 of Treatment A and B,
      electrocardiograms (ECGs) will be recorded continuously for 24 hours per day by Holter
      monitoring. Safety assessments (blood and urine tests, blood pressure, pulse,
      electrocardiogram, and physical examination) will follow a similar schedule and will be
      performed during each treatment period, up to 4 weeks after the last study drug intake.The
      pharmacokinetic characteristics (level-profile of TMC207 and moxifloxacin over time in the
      blood stream) will be evaluated by multiple blood samples from Day -1 tol Day 3. Participants
      in Group 1 will take a single 800-mg dose of TMC207 on Day 1 and a single dose of
      moxifloxacin placebo on Day 2 (Treatment A). Participants in Groups 2 and 3 will take a
      single dose of TMC207 placebo on Day 1 and a single 400-mg dose of moxifloxacin on Day 2
      (Treatment B).¿ The study duration will be 3 days without screening and follow-up period
      included.
    

Intervention name(s): Moxifloxacin; TMC207; TMC207 placebo; Moxifloxacin placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 capsule of moxifloxacin (400 mg/capsule) on Day 2; 8 tablets of TMC207 (100 mg/tablet) on Day 1; 8 tablets of TMC207 placebo on Day 1; 1 capsule of moxifloxacin placebo on Day 2
Intervention MeSH terms: Moxifloxacin; Bedaquiline; Diarylquinolines; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: TMC207TBC1003; TMC207; M.Tuberculosis; TBC; Moxifloxacin; ECG; QT/QTc; Healthy volunteers