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

QT/QTc Interval in Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03554304
• Other study ID #: W-5222-103
• Status: Completed
• Phase: Phase 1
• Start date: February 9, 2017
• Est. completion date: October 6, 2017

Study information

• Verified date: May 2018
• Source: Wockhardt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 6, 2017
• Est. primary completion date: June 5, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• QT/QTc Interval in Healthy Volunteers

Intervention

Drug:
• WCK 5222
FEP-ZID IV solution administered as either a 30- or 60-minute IV infusion)
• 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
• Moxifloxacin 400-mg
Moxifloxacin 400-mg positive control (overencapsulated tablet)

Locations

Country	Name	City	State
United States	Spaulding Clinical Research	West Bend	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Wockhardt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of delay in cardiac repolarization induced by WCK 5222	as shown by analysis of the QT interval.	0-4 days
Secondary	Incidence of adverse events to assess tolerability at the supratherapeutic dose to be used in the thorough QT evaluation	Tolerability will be assessed by review of number of AEs	0-4 days
Secondary	Incidence of AEs to assess the safety of high doses of single-dose administration of FEP-ZID	Safety will be assessed by review of adverse events (AEs), ECGs, and clinical laboratory safety test results	0-4 days