- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07813663
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP269 in Healthy Male and Female Participants
4 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
188
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Clinical Trial Disclosure & Transparency
- Numéro de téléphone: 215-832-3750
- E-mail: ClinicalTrialDisclosure@JazzPharma.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
Participants are eligible to be included in the study only if all of the following criteria apply:
- Is 18 to 55 years of age, inclusive, at the time of signing the informed consent.
- Is overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac/blood pressure monitoring.
- 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:
- Has a history of or presence of clinically significant medical illness as specified in the protocol.
- Has a family history (first degree relative) of torsades de pointes, premature sudden death, long QT syndrome, or clinically significant cardiac conduction disorders.
- Has a known or suspected history of schizophrenia or other psychotic illness or a history of severe personality disorder or other significant psychiatric disorder.
- 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.
- 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.
- 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).
- 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).
- 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.
- 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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: JZP269
Participants will receive JZP269.
|
Administered as described.
|
|
Comparateur placebo: Placebo
Participants will receive a matching placebo.
|
Administered as described.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants Reporting Treatment-emergent Adverse Events
Délai: 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
Délai: Predose up to 48 hours postdose
|
Predose up to 48 hours postdose
|
|
|
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of JZP269
Délai: Predose up to 48 hours postdose
|
Predose up to 48 hours postdose
|
|
|
Pharmacokinetic Parameter Apparent Terminal Elimination Half-life (t1/2) of JZP269
Délai: Predose up to 48 hours postdose
|
Predose up to 48 hours postdose
|
|
|
Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP269
Délai: 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
Délai: 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
Délai: Predose up to 48 hours postdose
|
Predose up to 48 hours postdose
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Dose Proportionality of JZP269 Area Under the Concentration-Time Curve (AUC)
Délai: 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)
Délai: Predose up to 48 hours postdose
|
Predose up to 48 hours postdose
|
|
|
The Effect of Food on the PK of JZP269 Cmax
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
22 septembre 2026
Achèvement primaire (Estimé)
27 février 2027
Achèvement de l'étude (Estimé)
27 février 2027
Dates d'inscription aux études
Première soumission
4 septembre 2026
Première soumission répondant aux critères de contrôle qualité
4 septembre 2026
Première publication (Réel)
10 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- JZP269-101
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .