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

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

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 Overview

• Status: Completed
• Conditions: QT/QTc Interval in Healthy Volunteers
• Intervention / Treatment: Drug: WCK 5222; Drug: IV placebo matched to WCK 5222 / Moxifloxacin IV solution; Drug: Moxifloxacin 400-mg

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • West Bend, Wisconsin, United States, 53095
      • Spaulding Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wockhardt

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2017
• Primary Completion (Actual): June 5, 2017
• Study Completion (Actual): October 6, 2017

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: May 30, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 13, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
• Other Study ID Numbers: W-5222-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No