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

4 de septiembre de 2026 actualizado por: Jazz Pharmaceuticals

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

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

Descripción general del estudio

Estado

Aún no reclutando

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

188

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: JZP269
Participants will receive JZP269.
Administered as described.
Comparador de placebos: Placebo
Participants will receive a matching placebo.
Administered as described.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants Reporting Treatment-emergent Adverse Events
Periodo de tiempo: Day 1 of dosing and monitoring period up to 7 days after last dose (Safety Follow Up Visit)
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
Periodo de tiempo: Predose up to 48 hours postdose
Predose up to 48 hours postdose
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of JZP269
Periodo de tiempo: Predose up to 48 hours postdose
Predose up to 48 hours postdose
Pharmacokinetic Parameter Apparent Terminal Elimination Half-life (t1/2) of JZP269
Periodo de tiempo: Predose up to 48 hours postdose
Predose up to 48 hours postdose
Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP269
Periodo de tiempo: 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∞).
Predose up to 48 hours postdose
Pharmacokinetic Parameter Oral Clearance (CL/F) of JZP269
Periodo de tiempo: Predose up to 48 hours postdose
Predose up to 48 hours postdose
Pharmacokinetic Parameter Apparent Volume of Distribution During the Terminal Phase (Vz/F) of JZP269
Periodo de tiempo: Predose up to 48 hours postdose
Predose up to 48 hours postdose

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Dose Proportionality of JZP269 Area Under the Concentration-Time Curve (AUC)
Periodo de tiempo: Predose up to 48 hours postdose
Dose proportionality of JZP269 AUC0-last, AUC∞, and AUC0-24 will be assessed.
Predose up to 48 hours postdose
Dose Proportionality of JZP269 Maximum Concentration (Cmax)
Periodo de tiempo: Predose up to 48 hours postdose
Predose up to 48 hours postdose
The Effect of Food on the PK of JZP269 Cmax
Periodo de tiempo: Predose up to 48 hours postdose
The effect of food on the PK of JZP269 relative to that observed in the fasted state will be assessed.
Predose up to 48 hours postdose
The Effect of Food on the PK of JZP269 Tmax
Periodo de tiempo: Predose up to 48 hours postdose
The effect of food on the PK of JZP269 relative to that observed in the fasted state will be assessed.
Predose up to 48 hours postdose
The Effect of Food on the PK of JZP269 t1/2
Periodo de tiempo: Predose up to 48 hours postdose
The effect of food on the PK of JZP269 relative to that observed in the fasted state will be assessed.
Predose up to 48 hours postdose
The Effect of Food on the PK of JZP269 AUC
Periodo de tiempo: Predose up to 48 hours postdose
The effect of food on the PK of JZP269 relative to that observed in the fasted state will be assessed.
Predose up to 48 hours postdose
Mean Concentrations of JZP269 in Cerebrospinal Fluid
Periodo de tiempo: Predose up to 48 hours postdose
Predose up to 48 hours postdose
Mean Sleep Latency on the Maintenance of Wakefulness Test (MWT) in Sleep-deprived Participants
Periodo de tiempo: Day 1 of dosing and monitoring period
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.
Day 1 of dosing and monitoring period
Mean Karolinska Sleepiness Scale (KSS) Score in Sleep-deprived Participants
Periodo de tiempo: Day 1 of dosing and monitoring period
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.
Day 1 of dosing and monitoring period

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

22 de septiembre de 2026

Finalización primaria (Estimado)

27 de febrero de 2027

Finalización del estudio (Estimado)

27 de febrero de 2027

Fechas de registro del estudio

Enviado por primera vez

4 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

4 de septiembre de 2026

Publicado por primera vez (Actual)

10 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • JZP269-101

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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