JZP441 for Sleep Deprivation
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?
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ascending nighttime doses of JZP441 or placebo while remaining awake during the day
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- JZP441
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jazz Pharmaceuticals
Lead Sponsor
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