Clinical Trials in the USA / NCT07813663
Recruiting
Phase 1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP269 in Healthy Male and Female Participants
NCT07813663 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Healthy Participants
Investigational drug(s) / intervention(s)
JZP269Placebo
JZP269: Administered as described.
Placebo: Administered as described.
Study summary
This study will characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of JZP269 in healthy participants.
Eligibility
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.
Primary outcome measure(s)
- Number of Participants Reporting Treatment-emergent Adverse Events — 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 — Predose up to 48 hours postdose
- Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of JZP269 — Predose up to 48 hours postdose
- Pharmacokinetic Parameter Apparent Terminal Elimination Half-life (t1/2) of JZP269 — Predose up to 48 hours postdose
- Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP269 — Predose up to 48 hours postdose
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∞). - Pharmacokinetic Parameter Oral Clearance (CL/F) of JZP269 — Predose up to 48 hours postdose
- Pharmacokinetic Parameter Apparent Volume of Distribution During the Terminal Phase (Vz/F) of JZP269 — Predose up to 48 hours postdose
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Celerion | Lincoln | Nebraska | Recruiting |
| Clinilabs | Eatontown | New Jersey | Not Yet Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07813663 on ClinicalTrials.gov ↗ ← All trials in the USA