NCT04844463

A Study of JNJ-68179280 in Healthy Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-68179280 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (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 the safety and tolerability of JNJ-68179280 compared with placebo after administration of single ascending oral doses of JNJ-68179280 administered to healthy participants (Part 1), multiple ascending oral doses of JNJ-68179280, administered to healthy participants once daily (Cohorts 1 through 4) or twice daily (Cohort 5) over 14 consecutive days (Part 2) and multiple ascending oral doses of an alternative JNJ-68179280 formulation, administered to healthy participants once daily over 14 consecutive days (Part 3 if conducted).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-68179280	JNJ-68179280 will be administered as an oral capsule.
OTHER	Placebo	Matching placebo will be administered as an oral capsule.

Timeline

• Start date: 2021-05-26
• Primary completion: 2023-03-07
• Completion: 2023-03-13
• First posted: 2021-04-14
• Last updated: 2025-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study