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

Wockhardt

Status and phase: Completed; Phase 1

Conditions: QT/QTc Interval in Healthy Volunteers

Treatments: Drug: WCK 5222; Drug: Moxifloxacin 400-mg; Drug: IV placebo matched to WCK 5222 / Moxifloxacin IV solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT03554304

W-5222-103

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

WCK 5222

Experimental group

Description:

WCK 5222 IV solution administered as either a 30- or 60-minute IV infusion)

Treatment:

Drug: IV placebo matched to WCK 5222 / Moxifloxacin IV solution

Drug: WCK 5222

Placebo (IV placebo matched toWCK 5222IV solution)

Placebo Comparator group

Description:

placebo capsule matched to moxifloxacin overencapsulated tablet IV placebo matched to WCK 5222 IV solution

Treatment:

Drug: IV placebo matched to WCK 5222 / Moxifloxacin IV solution

Moxifloxacin 400-mg

Active Comparator group

Description:

positive control

Treatment:

Drug: IV placebo matched to WCK 5222 / Moxifloxacin IV solution

Drug: Moxifloxacin 400-mg