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- Ensaio Clínico NCT07613710
A Trial to Test the Safety and Tolerability of Lu AH69593 in Adults That Are Healthy or Have Narcolepsy
Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single- and Multiple-ascending-dose Trial Investigating Safety, Tolerability, and Pharmacokinetics of Lu AH69593 in Healthy Participants, Including Open-label Cohorts to Explore Pharmacodynamic Properties in Participants With Narcolepsy, and Food Effect in Healthy Participants
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Email contact via H. Lundbeck A/S
- Número de telefone: +45 36301311
- E-mail: HQ_Medinfo@Lundbeck.com
Locais de estudo
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Helsinki, Finlândia, 00380
- Recrutamento
- Terveystalo Helsinki, Sleep Clinic
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Turku, Finlândia, 20520
- Concluído
- CRST, Clinical Research Services Turku
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Key Inclusion Criteria:
For all participants in any trial Part (A, B, C and D):
- The participant has a resting supine pulse ≥45 and ≤100 beats per minute (bpm) at the Screening Visit and at the Baseline Visit.
Specifically for participants in trial Part A, B, and D:
- The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms (kg)/square meter (m^2) at the Screening Visit.
- The participant has a normal circadian rhythm, defined as a person who usually wakes up between 6:00 and 9:00 a.m. and goes to sleep between 9:00 p.m. and midnight.
- The participant is ≥18 and ≤55 years of age at the Screening Visit.
Specifically for participants in trial Part C:
- The participant has a BMI ≥18.5 and ≤35 kg/m^2 at the Screening Visit.
- The participant has NT1, diagnosed according to International Classification of Sleep Disorders, 3rd edition criteria, with a history of disease diagnosis >3 months prior to the Screening Visit.
- The participant is ≥18 and ≤64 years of age at the Screening Visit.
Key Exclusion Criteria:
For all participants in any trial Part (A, B, C and D):
- The participant has previously been enrolled in this trial.
- The participant has previously been dosed with Lu AH69593.
- The participant has participated in a clinical trial <30 days prior to the Screening Visit.
- The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.
- The participant has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin or adequately treated cervical intraepithelial neoplasia, that has not been in remission for >5 years prior to the first dose of investigational medicinal product (IMP).
- The participant has worked shifts, including night duty, or has travelled across >3 time zones <2 weeks prior to the first dose of IMP.
- The participant trains/exercises intensively, for example, for a marathon or triathlon, or at a competitive level.
Specifically for participants in trial Part A, B and D:
- The participant has had a clinically significant illness from which he/she recovered <4 weeks prior to the first dose of IMP.
Specifically for Participants in trial Part B and C:
- The participant is at significant risk of suicide based on medical history, mental status, investigator judgement, or the C-SSRS answer of 'yes' to suicidal ideation question 4 or 5 or 'yes' to suicidal behaviour, within the last 6 months on the C-SSRS at the Screening Visit or 'Since last visit' at the Baseline Visit Day -1.
Specifically for participants in trial Part C:
- The participant has any other disorder for which the treatment takes priority over treatment of narcolepsy or is likely to interfere with trial treatment or impair treatment compliance.
- The participant has a current medical disorder, other than NT1, associated with excessive daytime sleepiness (EDS).
Note: Other protocol-defined inclusion and exclusion criteria may apply.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Part A (Single Ascending Dose [SAD] in Healthy Participants): Lu AH69593 or Placebo
Participants will receive single oral dose of Lu AH69593 or placebo.
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O placebo será administrado de acordo com o cronograma especificado na descrição do braço.
Lu AH69593 will be administered per schedule specified in the arm description.
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Experimental: Part B (Multiple Ascending Dose [MAD] in Healthy Participants): Lu AH69593 or Placebo
Participants will receive Lu AH69593 or placebo orally for 10 days.
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O placebo será administrado de acordo com o cronograma especificado na descrição do braço.
Lu AH69593 will be administered per schedule specified in the arm description.
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Experimental: Part C (MAD in Participants With Narcolepsy Type 1 [NT1]): Lu AH69593
Participants will receive Lu AH69593 orally for 84 days.
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Lu AH69593 will be administered per schedule specified in the arm description.
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Experimental: Part D (Food Effect in Healthy Participants): Lu AH69593
Participants with receive two single oral doses of Lu AH69593 in fasting or fed condition.
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Lu AH69593 will be administered per schedule specified in the arm description.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Prazo: Baseline up to Day 90
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Baseline up to Day 90
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Bond Lader Visual Analogue Scale (VAS) dimension scores (Alertness, Contentedness, and Calmness)
Prazo: Baseline up to Day 84
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Baseline up to Day 84
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Psychomotor Vigilance Task (PVT) Parameter - Change From Baseline in Reaction Time to Stimuli
Prazo: Baseline, up to Day 11
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Baseline, up to Day 11
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PVT Parameter - Change From Baseline in Number of Errors of Omission
Prazo: Baseline, up to Day 11
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Baseline, up to Day 11
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PVT Parameter - Change From Baseline in Number of Errors of Commission (Response Without Stimulus)
Prazo: Baseline, up to Day 11
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Baseline, up to Day 11
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Number of Participants With Suicidal Ideation and Behaviour Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Prazo: Baseline up to Day 90
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Baseline up to Day 90
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Area Under the Curve (AUC) From Zero to Time of Last Quantifiable Concentration (AUC0-t) of Lu AH69593
Prazo: Up to 84 days
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Up to 84 days
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Maximum Observed Plasma Concentration (Cmax) of Lu AH69593
Prazo: Up to 84 days
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Up to 84 days
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Time to Reach Cmax (Tmax) of Lu AH69593
Prazo: Up to 84 days
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Up to 84 days
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AUC From Time Zero to Infinity (AUC0-inf)
Prazo: Up to 6 days
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Up to 6 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Email contact via H. Lundbeck A/S, H. Lundbeck A/S
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20653A
- 2024-511073-29-00 (Ctis)
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