- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07813663
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP269 in Healthy Male and Female Participants
4. September 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
188
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Clinical Trial Disclosure & Transparency
- Telefonnummer: 215-832-3750
- E-Mail: ClinicalTrialDisclosure@JazzPharma.com
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: JZP269
Participants will receive JZP269.
|
Administered as described.
|
|
Placebo-Komparator: Placebo
Participants will receive a matching placebo.
|
Administered as described.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants Reporting Treatment-emergent Adverse Events
Zeitfenster: 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
Zeitfenster: Predose up to 48 hours postdose
|
Predose up to 48 hours postdose
|
|
|
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of JZP269
Zeitfenster: Predose up to 48 hours postdose
|
Predose up to 48 hours postdose
|
|
|
Pharmacokinetic Parameter Apparent Terminal Elimination Half-life (t1/2) of JZP269
Zeitfenster: Predose up to 48 hours postdose
|
Predose up to 48 hours postdose
|
|
|
Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP269
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Predose up to 48 hours postdose
|
Predose up to 48 hours postdose
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Dose Proportionality of JZP269 Area Under the Concentration-Time Curve (AUC)
Zeitfenster: 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)
Zeitfenster: Predose up to 48 hours postdose
|
Predose up to 48 hours postdose
|
|
|
The Effect of Food on the PK of JZP269 Cmax
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
22. September 2026
Primärer Abschluss (Geschätzt)
27. Februar 2027
Studienabschluss (Geschätzt)
27. Februar 2027
Studienanmeldedaten
Zuerst eingereicht
4. September 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
4. September 2026
Zuerst gepostet (Tatsächlich)
10. September 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
10. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
4. September 2026
Zuletzt verifiziert
1. September 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- JZP269-101
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Ja
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .