A Phase 1 interventional study of JZP269 and Placebo in Healthy Participants, sponsored by Jazz Pharmaceuticals. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Jazz Pharmaceuticals · Phase 1, Interventional, and Treatment
This study will characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of JZP269 in healthy participants.
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.
Jazz Pharmaceuticals is the lead sponsor of 173 studies on the registry; 18 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 32 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants are eligible to be included in the study only if all of the following criteria apply:
Participants are excluded from the study if any of the following criteria apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive JZP269.
Drug: JZP269
Participants will receive a matching placebo.
Drug: Placebo
Administered as described.
Administered as described.
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)
Pharmacokinetic Parameter Maximum Concentration (Cmax) of JZP269
Time frame: Predose up to 48 hours postdose
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of JZP269
Time frame: Predose up to 48 hours postdose
Pharmacokinetic Parameter Apparent Terminal Elimination Half-life (t1/2) of JZP269
Time frame: Predose up to 48 hours postdose
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∞).
Time frame: Predose up to 48 hours postdose
Pharmacokinetic Parameter Oral Clearance (CL/F) of JZP269
Time frame: Predose up to 48 hours postdose
Pharmacokinetic Parameter Apparent Volume of Distribution During the Terminal Phase (Vz/F) of JZP269
Time frame: Predose up to 48 hours postdose
Dose Proportionality of JZP269 Area Under the Concentration-Time Curve (AUC)
Dose proportionality of JZP269 AUC0-last, AUC∞, and AUC0-24 will be assessed.
Time frame: Predose up to 48 hours postdose
Dose Proportionality of JZP269 Maximum Concentration (Cmax)
Time frame: Predose up to 48 hours postdose
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.
Time frame: Predose up to 48 hours postdose
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.
Time frame: Predose up to 48 hours postdose
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.
Time frame: Predose up to 48 hours postdose
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.
Time frame: Predose up to 48 hours postdose
Mean Concentrations of JZP269 in Cerebrospinal Fluid
Time frame: Predose up to 48 hours postdose
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.
Time frame: Day 1 of dosing and monitoring period
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.
Time frame: Day 1 of dosing and monitoring period
Plan to share: 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.
Data sharing details ↗ · www.jazzpharma.com
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Feb 2027, 5 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.