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JZP441 for Sleep Deprivation
Phase 1
Waitlist Available
Research Sponsored by Jazz Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose and multiple post-dose timepoints, up to 36 hours
Awards & highlights
Study Summary
This trial will test a new drug to help people who don't get enough sleep. It will measure safety, body's response, and how long it stays in the body.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this is an early-phase trial for JZP441 in healthy individuals deprived of sleep, specific side effects aren't listed yet. Generally speaking though, potential side effects could include reactions at the site of administration (if applicable), changes in alertness levels or mood disturbances given its nature as a central nervous system-active compound.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-dose and multiple post-dose timepoints, up to 36 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and multiple post-dose timepoints, up to 36 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Treatment-emergent Adverse Events After Administration of JZP441 in Sleep-deprived Healthy Participants
Secondary outcome measures
Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP441
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) Levels of JZP441
Pharmacokinetic Parameter Time to Maximum Plasma Concentration (Tmax) of JZP441
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: JZP441Experimental Treatment1 Intervention
Participants who will be randomized to receive an oral dose of JZP441.
Group II: PlaceboPlacebo Group1 Intervention
Participants who will be randomized to receive an oral dose of placebo.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
34,227 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently pregnant, nursing, or lactating.My kidney function is impaired.I have been diagnosed with long-term insomnia.I have a condition that makes me excessively sleepy.I am currently diagnosed with or being treated for depression, have had a major depressive episode in the past 5 years, or have a history of suicidal thoughts or attempts.I have a history of serious heart problems.I have no conditions that affect how my body handles medication.I have been diagnosed with or am at high risk for sleep apnea.My ECG shows a QT interval longer than normal or other significant issues.I am generally healthy as confirmed by a recent medical check-up.I am between 18 and 50 years old.
Research Study Groups:
This trial has the following groups:- Group 1: JZP441
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Healthy Subjects Patient Testimony for trial: Trial Name: NCT05651152 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project include participants over the age of 80?
"The age range for participants in this clinical trial is 18 to 50, as stipulated by the inclusion criteria."
Answered by AI
What risks do individuals face when taking JZP441?
"JZP441 has not yet been thoroughly tested, so it only garnered a score of 1 on our safety scale. This is because Phase 1 trials offer limited evidence for both the efficacy and safety of the drug."
Answered by AI
Who can submit themselves for consideration in this experiment?
"To be eligible for this study, 132 subjects must meet the criteria of being a healthy individual and falling within an age range from 18 to 50."
Answered by AI
How many subjects are participating in this experiment?
"Affirmative. The clinical trial details on clinicaltrials.gov reveals that the study, which was first posted on November 28th 2022, is currently in its recruitment phase. 132 individuals are required to be enrolled from two distinct sites."
Answered by AI
Are additional participants being enrolled in this clinical experiment?
"Affirmative. Clinicaltrials.gov reveals that this particular experiment, published on November 28th 2022 and recently revised on December 13th 2022 is still recruiting participants. 132 volunteers are needed to be recruited from 2 sites for the study's completion."
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
New Jersey
New York
What site did they apply to?
Clinical Site 1
Clinical Site 2
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Interested in helping and additional income. I lack sleep and usually only sleeps for 5 hours.
PatientReceived 2+ prior treatments
I am a healthy volunteer looking for a source of income during my off season from work.
PatientReceived 1 prior treatment
How responsive is this trial?
Most responsive sites:
- Clinical Site 2: < 48 hours
Average response time
- < 2 Days
Typically responds via
Email
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