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

Study Overview
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Brief Summary
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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

Official Title
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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
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QT/QTc Interval in Healthy Volunteers

Intervention / Treatment
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* Drug: WCK 5222
* Drug: IV placebo matched to WCK 5222 / Moxifloxacin IV solution
* Drug: Moxifloxacin 400-mg


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WCK 5222<br>WCK 5222 IV solution administered as either a 30- or 60-minute IV infusion) | Drug: WCK 5222<br>* FEP-ZID IV solution administered as either a 30- or 60-minute IV infusion)<br>Drug: IV placebo matched to WCK 5222 / Moxifloxacin IV solution<br>* Placebo (IV placebo matched to FEP-ZID IV solution) and 1 placebo capsule matched to moxifloxacin overencapsulated tablet<br>* Other names: Placebo capsule matched to moxifloxacin;|
| Placebo Comparator: Placebo (IV placebo matched toWCK 5222IV solution)<br>placebo capsule matched to moxifloxacin overencapsulated tablet IV placebo matched to WCK 5222 IV solution | Drug: IV placebo matched to WCK 5222 / Moxifloxacin IV solution<br>* Placebo (IV placebo matched to FEP-ZID IV solution) and 1 placebo capsule matched to moxifloxacin overencapsulated tablet<br>* Other names: Placebo capsule matched to moxifloxacin;|
| Active Comparator: Moxifloxacin 400-mg<br>positive control | Drug: IV placebo matched to WCK 5222 / Moxifloxacin IV solution<br>* Placebo (IV placebo matched to FEP-ZID IV solution) and 1 placebo capsule matched to moxifloxacin overencapsulated tablet<br>* Other names: Placebo capsule matched to moxifloxacin;Drug: Moxifloxacin 400-mg<br>* Moxifloxacin 400-mg positive control (overencapsulated tablet)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of delay in cardiac repolarization induced by WCK 5222 | as shown by analysis of the QT interval. | 0-4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |