JZP441 for Sleep Deprivation

No longer recruiting at 1 trial location

Overseen By Clinical Trial Disclosure & Transparency

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Jazz Pharmaceuticals

Disqualifiers: Pregnancy, Cardiovascular disease, Depression, others

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effects of a new drug, JZP441, designed to help with sleep deprivation. Researchers will administer either JZP441 or a placebo (a harmless pill with no active drug) to participants to evaluate its effectiveness and potential side effects. The trial seeks healthy individuals who frequently experience sleep deprivation but do not have chronic insomnia or sleep apnea. Participants should not have major health conditions and should not currently experience depression or other psychiatric disorders. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, and participants will be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study is for healthy participants without certain medical conditions, it's possible that you may need to pause some medications. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that JZP441 is likely to be safe for humans?

Research shows that JZP441 is being tested for safety in individuals who don't get enough sleep. As these studies are just beginning, the primary goal is to determine if healthy individuals can take the treatment without issues. Although information is limited, this early phase typically identifies any side effects or reactions to the drug.

JZP441 is also under development for other conditions, such as narcolepsy, indicating some confidence in its safety. However, researchers are still studying its safety for sleep-deprived individuals. The trial is closely monitored to ensure participant safety during treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for sleep deprivation focus on improving sleep quality or increasing sleep duration. However, JZP441 is unique because it targets the brain's wakefulness pathways directly. This approach could potentially improve alertness and cognitive function without the need for more sleep, offering a novel solution for those who struggle with sleep deprivation. Researchers are excited about JZP441 because it could offer faster results and a new mechanism of action compared to traditional sleep aids, which mainly work by inducing sleep rather than enhancing wakefulness.

What evidence suggests that JZP441 might be an effective treatment for sleep deprivation?

Research has shown that JZP441 is being studied for its ability to help people stay awake. In this trial, participants will receive either JZP441 or a placebo at random. Although testing for sleep deprivation is still in its early stages, JZP441 has shown promise in treating narcolepsy, a condition that also affects sleep. In a study involving people with narcolepsy, JZP441 significantly improved alertness and reduced excessive sleepiness compared to those who took a placebo (a pill with no active medicine). These findings suggest that JZP441 might help with sleep-related problems and could benefit those who are sleep-deprived. However, more research is needed to confirm its effectiveness specifically for sleep deprivation. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

Healthy adults aged 18-50 can join this trial. They must pass a medical exam, including lab tests and heart monitoring, and not be pregnant or nursing. People with kidney issues, abnormal ECGs, significant allergies, mental health disorders like bipolar or schizophrenia, certain infections (HIV/hepatitis), chronic insomnia, major cardiovascular diseases or those who've recently been in other drug/device trials cannot participate.

Exclusion Criteria

I am currently pregnant, nursing, or lactating.

My kidney function is impaired.

I have been diagnosed with long-term insomnia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ascending nighttime doses of JZP441 or placebo while remaining awake during the day

1-2 weeks

Daily visits for dosing and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JZP441
• Placebo

Trial Overview The study is testing JZP441 against a placebo in sleep-deprived healthy people to see how safe it is and how the body reacts to different doses at night. It's a Phase 1 trial where participants are randomly assigned to get either the real drug or a fake pill without knowing which one they're taking.

How Is the Trial Designed?

Group I: JZP441 Experimental Treatment 1 Intervention

Participants who will be randomized to receive an oral dose of JZP441.

Group II: Placebo Placebo Group 1 Intervention

Participants who will be randomized to receive an oral dose of placebo.

Who Is Running the Clinical Trial?

Jazz Pharmaceuticals

Lead Sponsor

Trials

252

Recruited

35,100+

Bruce C. Cozadd

Jazz Pharmaceuticals

Chief Executive Officer since 2009

BA in Economics from Yale University, MBA from Stanford University

Dr. Austin

Jazz Pharmaceuticals

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Published Research Related to This Trial

In a study with 20 healthy adults, recovery from one night of total sleep deprivation was significantly better with 9 hours of sleep compared to 6 hours, highlighting the importance of total sleep time (TST) for recovery.

Participants who had only 6 hours of recovery sleep showed persistent deficits in waking functions, with response times and alertness remaining below baseline levels throughout the recovery period, indicating that restricted sleep opportunities hinder recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The characteristics of recovery sleep when recovery opportunity is restricted. Jay, SM., Lamond, N., Ferguson, SA., et al.[2019]

The sleep-deprivation paradigm is a valuable method for exploring the functions of sleep, and integrating new measures can provide fresh insights into its effects.

Recent studies highlight the importance of better understanding the consequences of insomnia, suggesting that more research is needed in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk-taking and other effects of sleep loss on brain function and behaviour. Dijk, DJ.[2011]

Citations

1. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-10-2022-339ec

JZP441 for Sleep Deprivation · Info for Participants This trial tests a new drug called JZP441 to see if it is safe and how it works in the body. The study involves healthy people who haven't had enough sleep.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05651152

NCT05651152 | A Study to Investigate The Safety ... This Phase 1, double-blind, randomized, placebo-controlled study will characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD)

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06961266

NCT06961266 | A Study to Investigate Efficacy, Safety ... JZP441 is currently being developed for the treatment of narcolepsy type 1 (NT1). This study will assess the safety of efficacy of JZP441 in adult patients with ...

4. jazzpharma.com jazzpharma.com/sites/jazzpharmaceuticals/files/2024-07/Jazz-Pharmaceuticals-Pipeline-Overview.pdf

Jazz Pharmaceuticals Pipeline Clinical Trials: The safety, tolerability, pharmacokinetics and pharmacodynamics of JZP441 are being investigated in healthy sleep-deprived adults.

5. withpower.com withpower.com/trial/phase-1-narcolepsy-3-2025-dca3e

JZP441 for Narcolepsy · Recruiting Participants for Phase ... In a phase 2b trial involving 93 adults with narcolepsy, JZP-110 significantly improved wakefulness and reduced excessive sleepiness compared to placebo, with ...

6. app.trialscreen.org app.trialscreen.org/trials/phase-1-healthy-participants-to-investigate-safety-tolerability-pharmacokinetics-trial-nct05651152

A Study to Investigate The Safety, Tolerability ... This study aims to analyze JZP441's safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in sleep-deprived healthy ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05651152/a-study-to-investigate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-jzp441-in-sleep-deprived-healthy-participants

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