NCT04844411

A Study of JNJ-67835989 in Healthy Participants

A Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-67835989 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the safety and tolerability of JNJ-67835989 versus placebo after single (or divided) oral dose administration (ascending dose levels) in healthy participants, pharmacokinetics (PK) of JNJ-67835989 in plasma and urine after single (or divided) oral dose administration in healthy participants, effects of JNJ-67835989 following single (or divided) oral dose administration in healthy participants on cardiovascular parameters, effects of JNJ-67835989 following single (or divided) oral dose administration on dissociative symptoms in healthy participants, and sedative effects of JNJ-67835989 following single (or divided) oral dose administration in healthy participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-67835989	JNJ-67835989 will be administered orally.
DRUG	Placebo	Matching placebo will be administered orally.

Timeline

• Start date: 2021-04-27
• Primary completion: 2022-05-18
• Completion: 2022-05-18
• First posted: 2021-04-14
• Last updated: 2025-04-27

Locations

1 site across 1 country: Belgium