NCT03405441

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

A 2-Part, Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-55375515 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: Male
• Age: 18 Years – 54 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-01-02
• Primary completion: 2018-09-04
• Completion: 2018-09-04
• First posted: 2018-01-23
• Last updated: 2025-04-27

Locations

1 site across 1 country: Netherlands