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JZP269

Phase 1

Healthy Participants | Small molecule | Other |Jazz Pharmaceuticals plc|Last Updated: Sep 10, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment188

FDA Designations

No designations recorded

Clinical trial landscape

JZP269 · 1 trial · 1 indication

Phase 1 1
NCT07813663A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP269 in Healthy Male and Female ParticipantsHealthy Participants
NOT YET_RECRUITING188 Analytics
PHASE1NOT YET_RECRUITING
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP269 in Healthy Male and Female Participants
Healthy Participants
NCT07813663188
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Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
JZP269EXPERIMENTALParticipants will receive JZP269.
PlaceboPLACEBO_COMPARATORParticipants will receive a matching placebo.

Interventions

NameTypeDescription
JZP269DRUGAdministered as described.
PlaceboDRUGAdministered as described.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

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, laborat...

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Recent Changes (Last 90 Days)

LOWSep 10, 2026NCT07813663NEW_TRIAL: changed
LOWSep 10, 2026NCT07813663NEW_TRIAL: changed