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

NCT03554304 | Completed Phase 1 FDA Drug

• 1 other identifier: W-5222-103
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

QT/QTc Interval in Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Incidence of delay in cardiac repolarization induced by WCK 5222

  as shown by analysis of the QT interval.

  0-4 days

Secondary Outcomes (2)

• Incidence of adverse events to assess tolerability at the supratherapeutic dose to be used in the thorough QT evaluation

  0-4 days

• Incidence of AEs to assess the safety of high doses of single-dose administration of FEP-ZID

  0-4 days

Study Arms (3)

WCK 5222

EXPERIMENTAL

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

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

Placebo (IV placebo matched toWCK 5222IV solution)

PLACEBO COMPARATOR

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

Moxifloxacin 400-mg

ACTIVE COMPARATOR

positive control

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

Interventions

WCK 5222 DRUG

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

WCK 5222

IV placebo matched to WCK 5222 / Moxifloxacin IV solution DRUG

Placebo (IV placebo matched to FEP-ZID IV solution) and 1 placebo capsule matched to moxifloxacin overencapsulated tablet

Also known as: Placebo capsule matched to moxifloxacin

Moxifloxacin 400-mg; Placebo (IV placebo matched toWCK 5222IV solution); WCK 5222

Moxifloxacin 400-mg DRUG

Moxifloxacin 400-mg positive control (overencapsulated tablet)

Moxifloxacin 400-mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Wockhardt: lead

Study Sites (1)

Spaulding Clinical Research

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Interventions

cefepime-zidebactam; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: June 13, 2018
• Study Start: February 9, 2017
• Primary Completion: June 5, 2017
• Study Completion: October 6, 2017
• Last Updated: June 13, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)