NCT03554304

Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers

A Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Wockhardt · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers

Conditions

• QT/QTc Interval in Healthy Volunteers

Interventions

Type	Name	Description
DRUG	WCK 5222	FEP-ZID IV solution administered as either a 30- or 60-minute IV infusion)
DRUG	IV placebo matched to WCK 5222 / Moxifloxacin IV solution	Placebo (IV placebo matched to FEP-ZID IV solution) and 1 placebo capsule matched to moxifloxacin overencapsulated tablet
DRUG	Moxifloxacin 400-mg	Moxifloxacin 400-mg positive control (overencapsulated tablet)

Timeline

• Start date: 2017-02-09
• Primary completion: 2017-06-05
• Completion: 2017-10-06
• First posted: 2018-06-13
• Last updated: 2018-06-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study