Effect of PA-824 and of PA-824 Plus Moxifloxacin on the QTc Interval in Healthy Volunteers
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, single-center, double-blinded, randomized, placebo-controlled, five-period
      cross-over clinical study of PA-824 to evaluate the effect of PA-824 and of PA-824 plus
      moxifloxacin on cardiac repolarization (QT/QTc interval duration) in a total of 75 healthy
      male and female participants, aged 18 to 45 years. Moxifloxacin will be used as an active
      control. Participants will be blinded to the treatments they will receive. The study consists
      of a screening period up to 26 days; enrollment, 1 day; five in-patient treatment periods
      consisting of an admission day (except in the first treatment period, when the pre-dose day
      is the baseline), dosing day and two post-dosing days; an out-patient period of at least
      three days and not more than 10 days between treatment periods; and a final visit 7 - 14 days
      after discharge from the last treatment period.
    

Detailed description: 
      This is a Phase I, single-center, double-blinded, randomized, placebo-controlled, five-period
      cross-over clinical study of PA-824 to evaluate the effect of PA-824 and of PA-824 plus
      moxifloxacin on cardiac repolarization (QT/QTc interval duration) in healthy male and female
      participants. Moxifloxacin will be used as an active control. Participants will be blinded to
      the treatments they will receive. The study consists of a screening period up to 26 days;
      enrollment, 1 day; five in-patient treatment periods consisting of an admission day (except
      in the first treatment period, when the pre-dose day is the baseline), dosing day and two
      post-dosing days; an out-patient period of at least three days and not more than 10 days
      between treatment periods; and a final visit 7 - 14 days after discharge from the last
      treatment period. During the study, the subjects will receive each one of the following five
      treatments: Treatment A: PA-824 placebo and moxifloxacin placebo; Treatment B: PA-824 400 mg
      plus moxifloxacin placebo; Treatment C: PA-824 1000 mg plus moxifloxacin placebo; Treatment
      D: PA-824 placebo plus moxifloxacin 400 mg; Treatment E: PA-824 400 mg plus moxifloxacin 400
      mg. The primary objective is to evaluate the effect of single-dose administration of PA-824
      400 mg and 1000 mg versus placebo on the QTcI interval. A total of 75 randomized (in order to
      have at least 60 evaluable) healthy male and female volunteers, aged 18 to 45 years will be
      enrolled.
    

Intervention name(s): Moxifloxacin; PA-824; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Moxifloxacin will be given orally to the following treatment groups, in combination with either PA-824 or PA-824 placebo: Treatment D: 400 mg + PA-824 placebo; Treatment E: 400 mg + PA-824 400 mg. Subjects will cross-over to the next Treatment Group after a 6-day washout period.; PA-824 will be given orally to the following treatment groups, together with either moxifloxacin or moxifloxacin placebo: Treatment B: 400 mg + moxifloxacin placebo; Treatment C: 1000 mg + moxifloxacin placebo; Treatment E: 400 mg + moxifloxacin 400 mg. Subjects will cross-over to the next Treatment Group after a 6-day washout period.; Placebo tablets to match Moxifloxacin or PA-824 will be given orally, in combination with either moxifloxacin or PA-824: Treatment A: PA-824 placebo + moxifloxacin placebo; Treatment B: PA-824 400 mg + moxifloxacin placebo; Treatment C: PA-824 1000 mg + moxifloxacin placebo Treatment D: PA-824 placebo + moxafloxacin 400 mg. Subjects will cross-over to the next Treatment Group after a 6-day washout period.
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tuberculosis, safety, PA-824, QTc interval, moxifloxacin, healthy volunteers, crossover