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

PHASE1CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

October 2, 2018

Primary Completion Date

December 13, 2019

Study Completion Date

December 13, 2019

Conditions
Healthy
Interventions
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.

Trial Locations (1)

2170

Clinical Pharmacology Unit, Merksem

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT03696459 - A Study to Evaluate the Effect of JNJ-53718678 on the Cardiac Repolarization Interval in Healthy Adult Participants | Biotech Hunter | Biotech Hunter