- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07813663
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP269 in Healthy Male and Female Participants
4 de setembro de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
188
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Clinical Trial Disclosure & Transparency
- Número de telefone: 215-832-3750
- E-mail: ClinicalTrialDisclosure@JazzPharma.com
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: JZP269
Participants will receive JZP269.
|
Administered as described.
|
|
Comparador de Placebo: Placebo
Participants will receive a matching placebo.
|
Administered as described.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants Reporting Treatment-emergent Adverse Events
Prazo: 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
Prazo: Predose up to 48 hours postdose
|
Predose up to 48 hours postdose
|
|
|
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of JZP269
Prazo: Predose up to 48 hours postdose
|
Predose up to 48 hours postdose
|
|
|
Pharmacokinetic Parameter Apparent Terminal Elimination Half-life (t1/2) of JZP269
Prazo: Predose up to 48 hours postdose
|
Predose up to 48 hours postdose
|
|
|
Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP269
Prazo: 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
Prazo: 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
Prazo: Predose up to 48 hours postdose
|
Predose up to 48 hours postdose
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Dose Proportionality of JZP269 Area Under the Concentration-Time Curve (AUC)
Prazo: 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)
Prazo: Predose up to 48 hours postdose
|
Predose up to 48 hours postdose
|
|
|
The Effect of Food on the PK of JZP269 Cmax
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
22 de setembro de 2026
Conclusão Primária (Estimado)
27 de fevereiro de 2027
Conclusão do estudo (Estimado)
27 de fevereiro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
4 de setembro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de setembro de 2026
Primeira postagem (Real)
10 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- JZP269-101
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .