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

NCT03696459 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2020-02-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-02
Primary Completion
2019-12-13
Completion
2019-12-13
FDA Drug
Yes

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03696459 on ClinicalTrials.gov