NCT02852395

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-48816274

A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-48816274

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Janssen-Cilag International NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a 3-part study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of JNJ-48816274 in healthy participants after administration of single and repeated doses, and to evaluate its potential effectiveness for treating insomnia.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-48816274	Oral dose; dose range of 5 mg up to 250 mg
DRUG	Placebo	Oral dose; appearance matched to JNJ-48816274

Timeline

• Start date: 2016-08-13
• Primary completion: 2018-05-02
• Completion: 2018-05-02
• First posted: 2016-08-02
• Last updated: 2025-04-27

Locations

2 sites across 1 country: United Kingdom