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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Wockhardt
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Incidence of delay in cardiac repolarization induced by WCK 5222
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Body mass index ≥18 to ≤33 kg/m2, inclusive.
- •Stable health based on a medical history without any major pathology/surgery in the 6 months
Exclusion Criteria
- •An uninterpretable or abnormal screening electrocardiogram (ECG) indicating a second- or third-degree atrioventricular block
- •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.
- •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).
Arms & Interventions
WCK 5222
WCK 5222 IV solution administered as either a 30- or 60-minute IV infusion)
Intervention: WCK 5222 (Drug)
WCK 5222
WCK 5222 IV solution administered as either a 30- or 60-minute IV infusion)
Intervention: IV placebo matched to WCK 5222 / Moxifloxacin IV solution (Drug)
Placebo (IV placebo matched toWCK 5222IV solution)
placebo capsule matched to moxifloxacin overencapsulated tablet IV placebo matched to WCK 5222 IV solution
Intervention: IV placebo matched to WCK 5222 / Moxifloxacin IV solution (Drug)
Moxifloxacin 400-mg
positive control
Intervention: IV placebo matched to WCK 5222 / Moxifloxacin IV solution (Drug)
Moxifloxacin 400-mg
positive control
Intervention: Moxifloxacin 400-mg (Drug)
Outcomes
Primary Outcomes
Incidence of delay in cardiac repolarization induced by WCK 5222
Time Frame: 0-4 days
as shown by analysis of the QT interval.
Secondary Outcomes
- Incidence of AEs to assess the safety of high doses of single-dose administration of FEP-ZID(0-4 days)
- Incidence of adverse events to assess tolerability at the supratherapeutic dose to be used in the thorough QT evaluation(0-4 days)