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A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55308942 in Healthy Male and Female Participants

NCT03151486 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-04-27

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of JNJ-55308942 in healthy participants after administration of single and multiple oral doses.

Conditions

  • Healthy

Interventions

DRUG

JNJ-55308942 0.5 mg

Participants will receive JNJ-55308942 0.5 mg as an oral solution after an overnight fast on Day 1.

DRUG

JNJ-55308942 1.5 mg

Participants will receive JNJ-55308942 1.5 mg as an oral solution after an overnight fast on Day 1.

DRUG

JNJ-55308942 4 mg

Participants will receive JNJ-55308942 4 mg as an oral solution after an overnight fast on Day 1.

DRUG

JNJ-55308942 12 mg

Participants will receive JNJ-55308942 12 mg as an oral solution after an overnight fast on Day 1.

DRUG

JNJ-55308942 36 mg

Participants will receive JNJ-55308942 36 mg as an oral solution after an overnight fast on Day 1.

DRUG

JNJ-55308942 100 mg

Participants will receive a single oral dose of JNJ-55308942 100 mg as an oral solution after an overnight fast on Day 1.

DRUG

JNJ-55308942: Fed State

Participants will receive JNJ-55308942 as an oral solution in fed state on Day 1. The dose selected for this cohort will be based on the data obtained from the single ascending dose cohorts.

DRUG

JNJ-55308942: MAD Part

Participants will receive JNJ-55308942 once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the MAD will be determined based on the data from the SAD part.

DRUG

Placebo

Participants will receive matching placebo in all cohorts.

Sponsors & Collaborators

  • Janssen-Cilag International NV

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag International NV Clinical Trial · Janssen-Cilag International NV

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-05-03
Primary Completion
2018-03-08
Completion
2018-03-08

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

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 NCT03151486 on ClinicalTrials.gov