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

Phase 1

Completed

• Conditions: QT/QTc Interval in Healthy Volunteers
• Interventions: Drug: WCK 5222; Drug: IV placebo matched to WCK 5222 / Moxifloxacin IV solution; Drug: Moxifloxacin 400-mg

• Registration Number: NCT03554304
• Lead Sponsor: Wockhardt

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-09
• Primary Completion: 2017-06-05
• Study Completion: 2017-10-06
• Status Verified: 2018-05
• Study First Submitted: 2018-05-16
• Study First Submitted QC: 2018-05-30
• Last Update Submitted: 2018-05-30
• Study First Posted: 2018-06-13
• Last Update Posted: 2018-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Body mass index ≥18 to ≤33 kg/m2, inclusive.
2. Stable health based on a medical history without any major pathology/surgery in the 6 months

Exclusion Criteria

1. An uninterpretable or abnormal screening electrocardiogram (ECG) indicating a second- or third-degree atrioventricular block
2. History of risk factors for torsades de pointes, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypocalcemia, or hypomagnesemia.
3. A sustained supine systolic blood pressure >150 mm Hg or <90 mm Hg or a supine diastolic blood pressure >95 mm Hg or <50 mm Hg at Screening or Check-in (Day -1).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Moxifloxacin 400-mg	Moxifloxacin 400-mg	positive control
WCK 5222	WCK 5222	WCK 5222 IV solution administered as either a 30- or 60-minute IV infusion)
Placebo (IV placebo matched toWCK 5222IV solution)	IV placebo matched to WCK 5222 / Moxifloxacin IV solution	placebo capsule matched to moxifloxacin overencapsulated tablet IV placebo matched to WCK 5222 IV solution
WCK 5222	IV placebo matched to WCK 5222 / Moxifloxacin IV solution	WCK 5222 IV solution administered as either a 30- or 60-minute IV infusion)
Moxifloxacin 400-mg	IV placebo matched to WCK 5222 / Moxifloxacin IV solution	positive control

Primary Outcome Measures

Name	Time	Method
Incidence of delay in cardiac repolarization induced by WCK 5222	0-4 days	as shown by analysis of the QT interval.

Secondary Outcome Measures

Name	Time	Method
Incidence of AEs to assess the safety of high doses of single-dose administration of FEP-ZID	0-4 days	Safety will be assessed by review of adverse events (AEs), ECGs, and clinical laboratory safety test results
Incidence of adverse events to assess tolerability at the supratherapeutic dose to be used in the thorough QT evaluation	0-4 days	Tolerability will be assessed by review of number of AEs

Trial Locations

Locations (1)

Spaulding Clinical Research; 🇺🇸 West Bend, Wisconsin, United States