Study to Evaluate the Effect Of WCK 2349 on the QT/QTc Interval in Health Volunteers
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|ClinicalTrials.gov Identifier: NCT02217930|
Recruitment Status : Completed
First Posted : August 15, 2014
Last Update Posted : October 29, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Qt Interval, Variation in||Drug: WCK 2349 Drug: Placebo Drug: Moxifloxacin||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||July 2015|
Placebo Comparator: Placebo
Placebo matched to WCK 2349, oral tablet(s)
Placebo matched to moxifloxacin overencapsulated tablet
Active Comparator: Moxifloxacin
Moxifloxacin 400 mg positive control (overencapsulated tablet)
Experimental: WCK 2349
WCK 2349 supratherapeutic dose determined in Part 1, oral tablet(s)
Drug: WCK 2349
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02217930
|United States, Wisconsin|
|Phase 1 unit : Spaulding Clinical Research, LLC|
|West Bend, Wisconsin, United States, 53095|
|Principal Investigator:||Carlos Sanabria, MD||Spaulding Clinical Research Inc.|