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A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-55375515 in Healthy Male Participants

NCT03405441 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-04-27

No results posted yet for this study

Summary

The purpose of this study is to assess safety and tolerability of day-time and night-time dosing of JNJ-55375515 in healthy male participants.

Conditions

  • Healthy

Interventions

DRUG

JNJ-55375515 Dose Level 1

Participants will receive JNJ-55375515 orally at a Dose level 1 in Part 1 of study.

DRUG

JNJ-55375515 Dose Level 2

Participants will receive JNJ-55375515 orally at a Dose level 2 in Part 1 of study.

DRUG

JNJ-55375515 Dose Level 3

Participants will receive JNJ-55375515 orally at a Dose level 3 in Part 1 of study.

DRUG

JNJ-55375515 Dose Level 4

Participants will receive JNJ-55375515 orally at a Dose level 4 in Part 1 of study.

DRUG

JNJ-55375515 Dose Level 5

Participants will receive JNJ-55375515 orally at a Dose level 5 in Part 1 of study.

DRUG

JNJ-55375515 Dose Level 6

Participants will receive JNJ-55375515 orally at a Dose level 6 in Part 1 of study.

DRUG

Placebo

All participants will receive matching placebo orally in Part 1 and Part 2 of the study.

DRUG

JNJ-55375515

Participants will receive JNJ-55375515 as per the assigned treatment 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
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-02
Primary Completion
2018-09-04
Completion
2018-09-04

Countries

  • Netherlands

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 NCT03405441 on ClinicalTrials.gov