NCT03606057

A Study to Investigate the Effect of JNJ-64565111 on Cardiac Repolarization (Corrected QT Interval) Compared With Placebo in Healthy Adults: a Thorough ECG Study Employing Placebo, JNJ-64565111, and a Positive Control (Moxifloxacin)

A Randomized, Double-Blind, Parallel, Nested Crossover Study to Investigate the Effect of JNJ-64565111 on Cardiac Repolarization (Corrected QT Interval) Compared With Placebo in Healthy Adults: a Thorough ECG Study Employing Placebo, JNJ-64565111, and a Positive Control (Moxifloxacin)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the effects on placebo-corrected change from baseline QT interval corrected for individual heart rate (QTcI) of JNJ-64565111 close to steady state on Day 26 and on electrocardiogram morphology at supratherapeutic exposures in otherwise healthy overweight/obese adults after 4 weeks of treatment with JNJ 64565111 administered subcutaneously once weekly.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-64565111	Participants will receive JNJ-64565111, subcutaneously on days 2, 9, 16, and 23.
DRUG	Moxifloxacin	Participants will receive moxifloxacin capsule on days 1 or 27 in a nested crossover manner.
DRUG	JNJ-64565111-matching Placebo	Participants will receive JNJ-64565111-matching Placebo vehicle solution subcutaneously on days 2, 9, 16, and 23.
DRUG	Moxifloxacin-matching Placebo	Participants will receive moxifloxacin-matching placebo capsule on days 1 and 27 in treatment group 1 and on day 1 or 27 in treatment group 2.

Timeline

• Start date: 2018-07-13
• Primary completion: 2019-02-08
• Completion: 2019-02-28
• First posted: 2018-07-30
• Last updated: 2020-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study