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

NCT07813663 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: JZP269-101
• Study Type: interventional
• Target: 188
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy Participants

Keywords

Healthy Participants; JZP269

Outcome Measures

Primary Outcomes (7)

• 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

  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∞).

  Predose up to 48 hours postdose

• 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

Secondary Outcomes (9)

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

  Predose up to 48 hours postdose

• Dose Proportionality of JZP269 Maximum Concentration (Cmax)

  Predose up to 48 hours postdose

• The Effect of Food on the PK of JZP269 Cmax

  Predose up to 48 hours postdose

• The Effect of Food on the PK of JZP269 Tmax

  Predose up to 48 hours postdose

• The Effect of Food on the PK of JZP269 t1/2

  Predose up to 48 hours postdose

Study Arms (2)

JZP269

EXPERIMENTAL

Participants will receive JZP269.

Drug: JZP269

Placebo

PLACEBO COMPARATOR

Participants will receive a matching placebo.

Drug: Placebo

Interventions

JZP269 DRUG

Administered as described.

JZP269

Placebo DRUG

Administered as described.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead
• Jazz Pharmaceuticals Ireland Limited: collaborator

Central Study Contacts

Clinical Trial Disclosure & Transparency

CONTACT

215-832-3750; ClinicalTrialDisclosure@JazzPharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: September 22, 2026
• Primary Completion (Estimated): February 27, 2027
• Study Completion (Estimated): February 27, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share