Qt Interval, Variation in Clinical Trial
Official title:
A Randomized, Double-Blind, Double-Dummy, Placebo- and Positive- Controlled, Crossover Study to Evaluate the Effect Of WCK 2349 on the QT/QTc Interval in Health Volunteers
The study designed to determine the effect induced by WCK 2349 on the QT interval.
The study will be conducted in two parts: 1) to determine the supratherapeutic dose; and 2)
to assess the safety of high doses of single-dose administration of WCK 2349 on the QT
interval.
Part 1 of this study will determine the supratherapeutic dose to be used in Part 2. Part
1will enroll 8 subjects at each of 4 dose levels (up to 32 subjects). Cohorts will be
staggered so that appropriate safety monitoring and follow-up can be performed for each
subject at each dose level.
Safety monitoring will be based upon review of AEs, ECGs and clinical laboratory test
results prior to escalation to the next dose level.
At the first dose level, 6 subjects will be randomly assigned to receive a single dose of
WCK 2349 at 1800 mg and 2 subjects will be randomly assigned to placebo. If this dose is
tolerated by subjects, and safety data allows, the next group will be initiated in the same
fashion at a dose of 2200 mg. If this dose is tolerated by subjects, and safety data allows,
the next group will be initiated in the same fashion at a dose of 2600 mg. If this dose is
tolerated by subjects, and safety data allows, the next group will be initiated in the same
fashion at a dose of 3000 mg. Based upon safety data, the highest safely tolerated dose in
Part 1 will be utilized as the supratherapeutic dose in Part 2.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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