NCT03696459

A Study to Evaluate the Effect of JNJ-53718678 on the Cardiac Repolarization Interval in Healthy Adult Participants

A Double-blind, Randomized, Placebo-controlled, 4-Period Cross-over Study to Evaluate the Effect of JNJ-53718678 on the Cardiac Repolarization Interval in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (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 effect of JNJ-53718678 on QT interval corrected for heart rate (QTc) changes using exposure response analysis in healthy adult participants (Part 2).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-53718678, 2000 mg	Participants will be administered JNJ-53718678, 2000 mg as oral suspension in Part 1 (Panel 1).
DRUG	JNJ-53718678, 3000 mg	Participants will be administered JNJ- 53718678, 3000 mg as oral suspension in Part 1 (Panel 2).
DRUG	JNJ-53718678, 4500 mg or Dose to be decided	Participants will be administered JNJ-53718678, 4500 mg as oral suspension in Part 1 (Panel 3). If this dose is considered safe and tolerable and if pharmacokinetic data require further dose escalation, then participants will receive JNJ-53718678 (Dose to be decided) in Part 1 (Panel 4). This dose (either from Panel 3 or Panel 4 ) will be used in Part 2 (Dose may be lower/higher based on review of safety, tolerability, and PK data obtained in Part 1).
DRUG	JNJ-53718678 500 mg	Participants will be administered JNJ-53718678, 500 mg as oral suspension in Part 2.
DRUG	JNJ-53718678 Placebo	Participants will be administered JNJ-53718678 matching placebo in Part 1 and 2.
DRUG	Moxifloxacin 400 mg	Participants will be administered moxifloxacin 400 mg as capsule in Part 2.
DRUG	Moxifloxacin Placebo	Participants will be administered moxifloxacin matching placebo in Part 2.

Timeline

• Start date: 2018-10-02
• Primary completion: 2019-12-13
• Completion: 2019-12-13
• First posted: 2018-10-04
• Last updated: 2020-02-18

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study