NCT05651152

A Study to Investigate The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP441 in Sleep-deprived Healthy Participants

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Nighttime Doses of JZP441 in Sleep-Deprived Healthy Participants: A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This Phase 1, double-blind, randomized, placebo-controlled study will characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ascending nighttime doses of JZP441 in sleep-deprived healthy participants.

Detailed description

This study will initially employ nighttime dosing in sleep-deprived healthy participants. Participants (up to 12 per cohort) will be randomized to study intervention. Participants will remain awake during the day and then will be dosed at night. Safety, tolerability, PK and PD assessments will be conducted for nighttime dose.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	JZP441	Nighttime oral dose
DRUG	Placebo	Nighttime oral dose

Timeline

• Start date: 2022-11-28
• Primary completion: 2023-11-15
• Completion: 2023-11-15
• First posted: 2022-12-14
• Last updated: 2024-07-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study