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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
80
Phase 1 unit : Spaulding Clinical Research, LLC
West Bend, Wisconsin, United States
Change in QTc interval
Time frame: Baseline and 48 hours
Highest dose of WCK 2349 tolerated
Time frame: Baseline and 48 hours
Number of Adverse Events
Time frame: Baseline and 7 days after the last dose
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