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Unknown

JZP441 for Healthy Subjects

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 day 1 up until 38 days after last dose of study drug, up to approximately 2 months
Awards & highlights

Study Summary

This trial is testing a new drug, JZP441, to treat narcolepsy and hypersomnolence that has been shown to help patients stay awake and reduce symptoms.

Who is the study for?
This trial is for healthy adults aged 18-50 with no gastrointestinal, liver, or kidney diseases that could affect drug processing. They must not have a history of substance abuse in the past two years and should not be using any medications that lower seizure threshold.Check my eligibility
What is being tested?
The study tests JZP441's safety and how it's processed by the body when given in increasing doses to healthy participants. It compares JZP441 against a placebo to see if it can help people with narcolepsy without causing harm.See study design
What are the potential side effects?
Potential side effects are not detailed here but will likely include monitoring for common drug-related issues such as digestive disturbances, changes in heart rhythm or blood pressure, allergic reactions, and neurological symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up until 38 days after last dose of study drug, up to approximately 2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up until 38 days after last dose of study drug, up to approximately 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Proportionality of JZP441 for Area Under the Concentration-Time Curve (AUC)
Dose Proportionality of JZP441 for Maximum Concentration (Cmax)
Number of Participants With Treatment-emergent Adverse Events
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: JZP441Experimental Treatment1 Intervention
Healthy participants who will be randomized to receive an oral dose of JZP441.
Group II: PlaceboPlacebo Group1 Intervention
Healthy participants who will be randomized to receive placebo.

Find a Location

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
34,261 Total Patients Enrolled

Media Library

JZP441 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05720494 — Phase 1
Healthy Subjects Research Study Groups: JZP441, Placebo
Healthy Subjects Clinical Trial 2023: JZP441 Highlights & Side Effects. Trial Name: NCT05720494 — Phase 1
JZP441 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05720494 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are teenagers within the age range of this experiment?

"This research initiative is looking for participants aged 18 and above, with a maximum age limit of 50."

Answered by AI

Is JZP441 a relatively safe medication for patients?

"The safety of JZP441 is rated at 1 because this phase 1 trial has only provided limited data on both its efficacy and security."

Answered by AI

Are any new participants being accepted for the experiment?

"Per the information on clinicaltrials.gov, this trial is open to new participants as of now. The original posting was made on January 26th 2023 and it has since been modified for the last time on January 31st 2023."

Answered by AI

To what degree is this medical trial restricted in terms of participant numbers?

"Affirmative. Data provided on clinicaltrials.gov suggests that this research endeavour, which was initially posted on the 26th of January 2023, is searching for participants currently. A total of 98 people are needed from 1 trial site."

Answered by AI

Who meets the criteria to take part in this clinical investigation?

"For this clinical trial, 98 healthy individuals aged 18 and 50 are being requested. In order to qualify, applicants must satisfy the following standards: have a birthday between 18-50 years of age at the time of signing consent forms; demonstrate physical health through medical history reviews, bodily exams, laboratory tests, and cardiac/blood pressure monitoring."

Answered by AI

Who else is applying?

What state do they live in?
Utah
What site did they apply to?
Clinical Site 1
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JZP441 in Healthy Participants
2023. "A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JZP441 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05720494.
~24 spots leftby Oct 2024
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