A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP269 in Healthy Male and Female Participants
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
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Fase 1
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Clinical Trial Disclosure & Transparency
- Numero di telefono: 215-832-3750
- Email: ClinicalTrialDisclosure@JazzPharma.com
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Sperimentale: JZP269
Participants will receive JZP269.
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Administered as described.
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Comparatore placebo: Placebo
Participants will receive a matching placebo.
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Administered as described.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Participants Reporting Treatment-emergent Adverse Events
Lasso di tempo: Day 1 of dosing and monitoring period up to 7 days after last dose (Safety Follow Up Visit)
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Day 1 of dosing and monitoring period up to 7 days after last dose (Safety Follow Up Visit)
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Pharmacokinetic Parameter Maximum Concentration (Cmax) of JZP269
Lasso di tempo: Predose up to 48 hours postdose
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Predose up to 48 hours postdose
|
|
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Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of JZP269
Lasso di tempo: Predose up to 48 hours postdose
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Predose up to 48 hours postdose
|
|
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Pharmacokinetic Parameter Apparent Terminal Elimination Half-life (t1/2) of JZP269
Lasso di tempo: Predose up to 48 hours postdose
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Predose up to 48 hours postdose
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|
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Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP269
Lasso di tempo: 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∞).
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Predose up to 48 hours postdose
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Pharmacokinetic Parameter Oral Clearance (CL/F) of JZP269
Lasso di tempo: Predose up to 48 hours postdose
|
Predose up to 48 hours postdose
|
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Pharmacokinetic Parameter Apparent Volume of Distribution During the Terminal Phase (Vz/F) of JZP269
Lasso di tempo: Predose up to 48 hours postdose
|
Predose up to 48 hours postdose
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Dose Proportionality of JZP269 Area Under the Concentration-Time Curve (AUC)
Lasso di tempo: Predose up to 48 hours postdose
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Dose proportionality of JZP269 AUC0-last, AUC∞, and AUC0-24 will be assessed.
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Predose up to 48 hours postdose
|
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Dose Proportionality of JZP269 Maximum Concentration (Cmax)
Lasso di tempo: Predose up to 48 hours postdose
|
Predose up to 48 hours postdose
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The Effect of Food on the PK of JZP269 Cmax
Lasso di tempo: Predose up to 48 hours postdose
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The effect of food on the PK of JZP269 relative to that observed in the fasted state will be assessed.
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Predose up to 48 hours postdose
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The Effect of Food on the PK of JZP269 Tmax
Lasso di tempo: Predose up to 48 hours postdose
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The effect of food on the PK of JZP269 relative to that observed in the fasted state will be assessed.
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Predose up to 48 hours postdose
|
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The Effect of Food on the PK of JZP269 t1/2
Lasso di tempo: 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
|
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The Effect of Food on the PK of JZP269 AUC
Lasso di tempo: 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
|
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Mean Concentrations of JZP269 in Cerebrospinal Fluid
Lasso di tempo: Predose up to 48 hours postdose
|
Predose up to 48 hours postdose
|
|
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Mean Sleep Latency on the Maintenance of Wakefulness Test (MWT) in Sleep-deprived Participants
Lasso di tempo: Day 1 of dosing and monitoring period
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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.
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Day 1 of dosing and monitoring period
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Mean Karolinska Sleepiness Scale (KSS) Score in Sleep-deprived Participants
Lasso di tempo: Day 1 of dosing and monitoring period
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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.
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Day 1 of dosing and monitoring period
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Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- JZP269-101
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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