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A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JZP441 in Healthy Participants

Healthy Participants Clinical Trial

Official title:
Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of JZP441 in Healthy Adult Participants: A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study

Clinical Trial Summary

Treatments for narcolepsy and hypersomnolence disorders should have good oral bioavailability and brain penetration properties. JZP441 has demonstrated wake-promoting efficacy and anticataplectic activity in nonclinical studies and may represent a novel approach for these patients.

Clinical Trial Description

This Phase 1, double-blind, randomized, placebo-controlled, parallel group study is designed to characterize the safety, tolerability, and PK of multiple ascending doses of JZP441 for up to 4 weeks in healthy adult participants. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05720494
Study type Interventional
Source Jazz Pharmaceuticals
Contact
Status Active, not recruiting
Phase Phase 1
Start date January 26, 2023
Completion date October 1, 2024
View Details
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