NCT03151486

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

A Double-Blind, Placebo-Controlled, Randomized Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55308942 in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Janssen-Cilag International NV · Industry
• Sex: All
• Age: 18 Years – 58 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2017-05-03
• Primary completion: 2018-03-08
• Completion: 2018-03-08
• First posted: 2017-05-12
• Last updated: 2025-04-27

Locations

1 site across 1 country: Belgium