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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-09

Study Completion Date

2017-10-06

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

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Detailed Description

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Conditions

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QT/QTc Interval in Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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WCK 5222

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

Group Type EXPERIMENTAL

WCK 5222

Intervention Type DRUG

FEP-ZID IV solution administered as either a 30- or 60-minute IV infusion)

IV placebo matched to WCK 5222 / Moxifloxacin IV solution

Intervention Type DRUG

Placebo (IV placebo matched to FEP-ZID IV solution) and

1 placebo capsule matched to moxifloxacin overencapsulated tablet

Placebo (IV placebo matched toWCK 5222IV solution)

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

Group Type PLACEBO_COMPARATOR

IV placebo matched to WCK 5222 / Moxifloxacin IV solution

Intervention Type DRUG

Placebo (IV placebo matched to FEP-ZID IV solution) and

1 placebo capsule matched to moxifloxacin overencapsulated tablet

Moxifloxacin 400-mg

positive control

Group Type ACTIVE_COMPARATOR

IV placebo matched to WCK 5222 / Moxifloxacin IV solution

Intervention Type DRUG

Placebo (IV placebo matched to FEP-ZID IV solution) and

1 placebo capsule matched to moxifloxacin overencapsulated tablet

Moxifloxacin 400-mg

Intervention Type DRUG

Moxifloxacin 400-mg positive control (overencapsulated tablet)

Interventions

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WCK 5222

FEP-ZID IV solution administered as either a 30- or 60-minute IV infusion)

Intervention Type DRUG

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

Intervention Type DRUG

Moxifloxacin 400-mg

Moxifloxacin 400-mg positive control (overencapsulated tablet)

Intervention Type DRUG

Other Intervention Names

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Placebo capsule matched to moxifloxacin

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes