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Healthy ParticipantsPhase 1NCT07813663

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP269 in Healthy Male and Female Participants

A Phase 1 study testing JZP269 in people with Healthy Participants, run by Jazz Pharmaceuticals at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of JZP269 in healthy participants. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
JZP269
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
212 participants
Where
2 sitesUnited States
Study dates
22 Sep 2026to 27 Feb 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trial Disclosure & Transparency contact

215-832-3750

ClinicalTrialDisclosure@JazzPharma.com

United States2 sites, 2 recruiting

  • Clinilabs

    Eatontown, New Jersey, 07724

    Not yet recruiting

  • Celerion

    Lincoln, Nebraska, 68502

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double-Blind, Sponsor-Unblinded, Placebo-Controlled, Single-Ascending Dose and Multiple-Ascending Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP269 in Healthy Male and Female Participants

This study will characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of JZP269 in healthy participants.

Read the detailed description

This first-in-human study is designed to characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of JZP269, an orexin-2 receptor agonist, in healthy participants. The study will also assess the effect of food on JZP269 PK, characterize cerebrospinal fluid (CSF) exposure, and evaluate the wake-promoting PD effects using the Maintenance of Wakefulness Test (MWT) and Karolinska Sleepiness Scale (KSS) in sleep-deprived participants.

Being tested
JZP269, Placebo
Keywords
Healthy Participants, JZP269

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JZP269Drug

    Administered as described.

  • PlaceboDrug

    Administered as described.

Study groups in NCT07813663
Study groupRoleWhat they receive
JZP269ExperimentalParticipants will receive JZP269.
Receives: Drug: JZP269
PlaceboPlacebo comparatorParticipants will receive a matching placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Reporting Treatment-emergent Adverse Events

    Measured: Day 1 of dosing and monitoring period up to 7 days after last dose (Safety Follow Up Visit)

  2. Pharmacokinetic Parameter Maximum Concentration (Cmax) of JZP269

    Measured: Predose up to 48 hours postdose

  3. Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of JZP269

    Measured: Predose up to 48 hours postdose

  4. Pharmacokinetic Parameter Apparent Terminal Elimination Half-life (t1/2) of JZP269

    Measured: Predose up to 48 hours postdose

  5. Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP269

    Area under the concentration-time curve from time 0 to 24 hours (AUC0-24), area under the concentration time curve from time 0 to the last measurable concentration (AUC0-last), and area under the concentration-time curve from time 0 to infinity will be assessed (AUC∞).

    Measured: Predose up to 48 hours postdose

  6. Pharmacokinetic Parameter Oral Clearance (CL/F) of JZP269

    Measured: Predose up to 48 hours postdose

  7. Pharmacokinetic Parameter Apparent Volume of Distribution During the Terminal Phase (Vz/F) of JZP269

    Measured: Predose up to 48 hours postdose

Secondary outcomes (9)

  1. Dose Proportionality of JZP269 Area Under the Concentration-Time Curve (AUC)

    Dose proportionality of JZP269 AUC0-last, AUC∞, and AUC0-24 will be assessed.

    Measured: Predose up to 48 hours postdose

  2. Dose Proportionality of JZP269 Maximum Concentration (Cmax)

    Measured: Predose up to 48 hours postdose

  3. The Effect of Food on the PK of JZP269 Cmax

    The effect of food on the PK of JZP269 relative to that observed in the fasted state will be assessed.

    Measured: Predose up to 48 hours postdose

  4. The Effect of Food on the PK of JZP269 Tmax

    The effect of food on the PK of JZP269 relative to that observed in the fasted state will be assessed.

    Measured: Predose up to 48 hours postdose

  5. The Effect of Food on the PK of JZP269 t1/2

    The effect of food on the PK of JZP269 relative to that observed in the fasted state will be assessed.

    Measured: Predose up to 48 hours postdose

  6. The Effect of Food on the PK of JZP269 AUC

    The effect of food on the PK of JZP269 relative to that observed in the fasted state will be assessed.

    Measured: Predose up to 48 hours postdose

  7. Mean Concentrations of JZP269 in Cerebrospinal Fluid

    Measured: Predose up to 48 hours postdose

  8. Mean Sleep Latency on the Maintenance of Wakefulness Test (MWT) in Sleep-deprived Participants

    The MWT measures a participant's ability to remain awake under quiet conditions during the day. Sleep latency is the time it takes for a participant to fall asleep while trying to remain awake during the MWT, and sleep onset is determined objectively by electroencephalography. The MWT calculates mean sleep latency as the average time to sleep onset. Shorter mean sleep latency indicates a greater difficulty maintaining wakefulness.

    Measured: Day 1 of dosing and monitoring period

  9. Mean Karolinska Sleepiness Scale (KSS) Score in Sleep-deprived Participants

    The KSS is a 9-point scale that measures subjective sleepiness during the preceding 10 minutes, ranging from 1 ("extremely alert") to 9 ("very sleepy, great effort to keep awake, fighting sleep"). Higher scores indicate greater sleepiness.

    Measured: Day 1 of dosing and monitoring period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2026
  2. Study start22 Sep 2026
  3. Primary completion27 Feb 2027 (estimated)
  4. Study completion27 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
212 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07813663
Sponsor's protocol ID
JZP269-101
Status last verified
Nov 2026
First submitted
4 Sep 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JZP269 in people with Healthy Participants, run by Jazz Pharmaceuticals at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trial Disclosure & Transparency (215-832-3750, ClinicalTrialDisclosure@JazzPharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting Treatment-emergent Adverse Events (time frame: Day 1 of dosing and monitoring period up to 7 days after last dose (Safety Follow Up Visit)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07813663.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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