QT/QTc Interval in Healthy Volunteers
Conditions
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
Interventions
DRUGWCK 5222
FEP-ZID IV solution administered as either a 30- or 60-minute IV infusion)
DRUGIV 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
DRUGMoxifloxacin 400-mg
Moxifloxacin 400-mg positive control (overencapsulated tablet)
Sponsors
Wockhardt
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of delay in cardiac repolarization induced by WCK 5222 | 0-4 days | as shown by analysis of the QT interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Outcome results
None listed