NCT03346122

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate safety and tolerability of JNJ-64991524 compared with placebo after administration of single ascending oral doses of JNJ-64991524 (Part 1) and multiple ascending oral doses of JNJ-64991524 (Part 2) in healthy participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-64991524 Dose Level 1	Participants will receive JNJ-64991524 at a Dose Level 1 in SAD Part 1 of study.
DRUG	JNJ-64991524 Dose Level 2	Participants will receive JNJ-64991524 at a Dose Level 2 in SAD Part 1 of study.
DRUG	JNJ-64991524 Dose Level 3	Participants will receive JNJ-64991524 at a Dose Level 3 in SAD Part 1 of study.
DRUG	JNJ-64991524 Dose Level 4	Participants will receive JNJ-64991524 at a Dose Level 4 in SAD Part 1 of study.
DRUG	JNJ-64991524 Dose Level 5	Participants will receive JNJ-64991524 at a dose of Dose Level 5 in SAD Part 1 of study.
DRUG	JNJ-64991524 Dose Level 6	Participants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study.
DRUG	Placebo	Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
DRUG	JNJ-64991524 Dose Level 7	Participants will receive JNJ-64991524 at a dose of Dose Level 7 in MAD Part 2 of study for 14 days.
DRUG	JNJ-64991524 Dose Level 8	Participants will receive JNJ-64991524 at a Dose Level 8 in MAD Part 2 of study for 14 days.
DRUG	JNJ-64991524 Dose Level 9	Participants will receive JNJ-64991524 at a Dose Level 9 in MAD Part 2 of study for 14 days.

Timeline

• Start date: 2017-11-15
• Primary completion: 2018-11-20
• Completion: 2018-11-20
• First posted: 2017-11-17
• Last updated: 2019-01-24

Locations

1 site across 1 country: Belgium