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

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

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07813663
Enrollment
188
Registered
2026-09-10
Start date
2026-09-22
Completion date
2027-02-27
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

Healthy Participants, JZP269

Brief summary

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

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.

Interventions

DRUGJZP269

Administered as described.

DRUGPlacebo

Administered as described.

Sponsors

Jazz Pharmaceuticals
Lead SponsorINDUSTRY
Jazz Pharmaceuticals Ireland Limited
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Reporting Treatment-emergent Adverse EventsDay 1 of dosing and monitoring period up to 7 days after last dose (Safety Follow Up Visit)
Pharmacokinetic Parameter Maximum Concentration (Cmax) of JZP269Predose up to 48 hours postdose
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of JZP269Predose up to 48 hours postdose
Pharmacokinetic Parameter Apparent Terminal Elimination Half-life (t1/2) of JZP269Predose up to 48 hours postdose
Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP269Predose up to 48 hours postdoseArea 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∞).
Pharmacokinetic Parameter Oral Clearance (CL/F) of JZP269Predose up to 48 hours postdose
Pharmacokinetic Parameter Apparent Volume of Distribution During the Terminal Phase (Vz/F) of JZP269Predose up to 48 hours postdose

Secondary

MeasureTime frameDescription
Dose Proportionality of JZP269 Area Under the Concentration-Time Curve (AUC)Predose up to 48 hours postdoseDose proportionality of JZP269 AUC0-last, AUC∞, and AUC0-24 will be assessed.
Dose Proportionality of JZP269 Maximum Concentration (Cmax)Predose up to 48 hours postdose
The Effect of Food on the PK of JZP269 CmaxPredose up to 48 hours postdoseThe effect of food on the PK of JZP269 relative to that observed in the fasted state will be assessed.
The Effect of Food on the PK of JZP269 TmaxPredose up to 48 hours postdoseThe effect of food on the PK of JZP269 relative to that observed in the fasted state will be assessed.
The Effect of Food on the PK of JZP269 t1/2Predose up to 48 hours postdoseThe effect of food on the PK of JZP269 relative to that observed in the fasted state will be assessed.
The Effect of Food on the PK of JZP269 AUCPredose up to 48 hours postdoseThe effect of food on the PK of JZP269 relative to that observed in the fasted state will be assessed.
Mean Concentrations of JZP269 in Cerebrospinal FluidPredose up to 48 hours postdose
Mean Sleep Latency on the Maintenance of Wakefulness Test (MWT) in Sleep-deprived ParticipantsDay 1 of dosing and monitoring periodThe 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.
Mean Karolinska Sleepiness Scale (KSS) Score in Sleep-deprived ParticipantsDay 1 of dosing and monitoring periodThe 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.

Contacts

CONTACTClinical Trial Disclosure & Transparency
ClinicalTrialDisclosure@JazzPharma.com215-832-3750

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026