NCT03607513

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-64264681 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-64264681 in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 58 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of JNJ-64264681 in healthy participants after single and multiple oral doses.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-64264681	For all cohorts except the solid dose formulation cohort, JNJ-64264681 wlll be administered as oral solution. For the solid dose formulation cohort, JNJ-64264681 will be provided as capsules for oral administration.
DRUG	Placebo	Matching placebo to JNJ-64264681 will be administered as oral solution.

Timeline

• Start date: 2018-07-31
• Primary completion: 2019-08-09
• Completion: 2019-08-09
• First posted: 2018-07-31
• Last updated: 2025-02-03

Locations

1 site across 1 country: Belgium