Effect of PA-824 and of PA-824 Plus Moxifloxacin on the QTc Interval in Healthy Volunteers
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Fluoroquinolones Moxifloxacin Norgestimate, ethinyl estradiol drug combination