JZP269 safety and PK/PD in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human trial characterizes safety, tolerability, pharmacokinetics, and pharmacodynamics of JZP269 in healthy volunteers. It also examines how food affects drug exposure, measures CSF exposure, and evaluates wake-promoting effects in sleep-deprived participants using the Maintenance of Wakefulness Test and the Karolinska Sleepiness Scale. Participants receive JZP269 or placebo in a controlled, supervised setting across multiple cohorts and dosing conditions. The study excludes individuals with significant medical or psychiatric histories and any cardiac conditions that increase risk. The trial is conducted at clinical research sites in Lincoln, Nebraska, and Eatontown, New Jersey, sponsored by Jazz Pharmaceuticals.

Why it matters

Who can join: the full rules

Participants are eligible to be included in the study only if all of the following criteria apply:

1. Is 18 to 55 years of age, inclusive, at the time of signing the informed consent.
2. Is overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac/blood pressure monitoring.
3. Has a body weight of at least 45 kg and BMI within the range of 18.5 to 30 kg/m\^2 (inclusive).

Participants are excluded from the study if any of the following criteria apply:

1. Has a history of or presence of clinically significant medical illness as specified in the protocol.
2. Has a family history (first degree relative) of torsades de pointes, premature sudden death, long QT syndrome, or clinically significant cardiac conduction disorders.
3. Has a known or suspected history of schizophrenia or other psychotic illness or a history of severe personality disorder or other significant psychiatric disorder.
4. Has a history (within 5 past years) or presence of diagnosis of alcohol abuse or alcohol use disorder, substance abuse or substance use disorder, or known drug dependence or is seeking treatment for an alcohol or substance abuse related disorder.
5. Has a current diagnosis of or is receiving treatment for depression or has a history (within past 5 years) of clinically significant major depressive episode.
6. Has a history of suicide attempt, a current suicidal risk as determined from history, or the presence of active suicidal ideation as indicated by a positive response to Item 4 or Item 5 on the C-SSRS (within the past 24 months).
7. In participants where cerebrospinal fluid will be collected, any contraindications to lumbar puncture including increased intracranial pressure, conditions that may lead to brain herniation, a history of degenerative spine disease or lumbar spinal stenosis, a history of lumbar surgery, or prior history of adverse experience with lumbar puncture (eg, headache).
8. Has a clinically significant ECG abnormality per investigator assessment or an average PR \> 200 msec, average QRS \> 110 msec, average QTcF \> 440 msec for men and women, or flattened or difficult to distinguish T-waves.
9. Has a resting supine systolic blood pressure \> 140 mmHg or \< 90 mmHg, resting supine diastolic blood pressure \> 90 mmHg or \< 50 mmHg, or resting supine heart rate \> 100 bpm or \< 40 bpm at screening or check-in.

Where it's running

• Celerion
  Lincoln, Nebraska, United States Recruiting
• Clinilabs
  Eatontown, New Jersey, United States Not yet recruiting

Study contacts

• Study coordinator: Clinical Trial Disclosure & Transparency
• Email: ClinicalTrialDisclosure@JazzPharma.com
• Phone: 215-832-3750

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.