drugset / Trial / NCT02217930

Study to Evaluate the Effect Of WCK 2349 on the QT/QTc Interval in Health Volunteers

NCT02217930 ↗

Phase 1 Completed 80 enrolled Wockhardt
RandomizedCrossoverTriple-blind

Summary

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.

Timeline

Start
2014-08
Primary completion
2014-12
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Moxifloxacin Small molecule 400 mg —
Subject WCK 2349 Unknown 1800 mg Oral
Subject WCK 2349 Unknown 2200 mg Oral
Subject WCK 2349 Unknown 2600 mg Oral
Subject WCK 2349 Unknown 3000 mg Oral

Indications