JZP441 for Sleep Deprivation

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

105 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug JZP441 for sleep deprivation?

The research on temazepam, a drug used for sleep issues, shows it can help people fall asleep faster and sleep longer, which might suggest that JZP441 could have similar effects for sleep deprivation. ^{1 2 3 4 5}

What is the purpose of this trial?

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. Participants will take the drug, and researchers will monitor its effects and how it moves through their bodies.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Temazepam's efficacy in patients with sleep onset insomnia. [2019]

2. England pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

The characteristics of recovery sleep when recovery opportunity is restricted. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of sleep deprivation on daytime sleepiness in primary insomnia. [2009]

5. England pubmed.ncbi.nlm.nih.gov

Nonrestorative sleep. [2022]