Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function
Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Hepatic Function
This clinical research trial is testing the investigational medicinal product (IMP) petrelintide that is being developed for body weight reduction in people living with obesity or overweight who have comorbidities.
The aim of this clinical research trial is to investigate whether the pharmacokinetics (PK) of petrelintide will be different in people with hepatic impairment (HI) compared to people with normal hepatic function.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This is a Phase 1, open-label, multicenter, single-dose, parallel-group, non-randomized trial to evaluate the PK, safety, and tolerability of petrelintide after a single dose in participants with mild, moderate, or severe HI, and participants with normal hepatic function. Allocation of participants to the hepatic function groups will be based on Child-Pugh classification.
Each participant will receive a single subcutaneous (SC) dose of petrelintide on Day 1.
Up to 18 participants with normal hepatic function and 18 participants with HI (6 participants each in the following groups: mild, moderate, or severe HI) will participate in this trial.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Clinical Trial Information Desk
- Número de telefone: +4588773600
- E-mail: clinicaltrials@zealandpharma.com
Locais de estudo
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Bratislava Region
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Bratislava, Bratislava Region, Eslováquia, 831 01
- Recrutamento
- Summit Clinical Research s.r.o.
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Contato:
- Viera Kupčová, Dr.
- Número de telefone: +421905286213
- E-mail: viera.kupcova@summit-cr.eu
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Malacky
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Malacky, Malacky, Eslováquia, 901 01
- Recrutamento
- Summit Clinical Research s.r.o.
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Contato:
- Edita Kadlubiaková, Dr.
- Número de telefone: +421905434699
- E-mail: edita.kadlubiakova@summit-cr.eu
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Poland
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Wroclaw, Poland, Polônia, 51-162
- Recrutamento
- Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
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Contato:
- Piotr Napora, Dr.
- Número de telefone: +483267900
- E-mail: napora.piotr@cbk.wroc.pl
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
All participants:
- Sex: male and female participants.
Body mass index (BMI): 18.5 to 40.0 kg/m^2, inclusive, at screening.
Additional Inclusion Criteria for Participants with Normal Hepatic Function
- Participants who are considered healthy as determined by medical history, physical examination, and other screening procedures, with clinically normal hepatic function at screening..
Clinical laboratory test results within normal reference range for the population, or results with acceptable deviations that are judged not to be clinically significant by the Investigator.
Additional Inclusion Criteria for Participants with Hepatic Impairment
- Participants with stable HI for at least 3 months, classified as Child-Pugh Grade A, B, or C as assessed by the Investigator.
- Participants should be otherwise judged to be in acceptable health (type 2 diabetes mellitus [T2DM] is allowed) in the opinion of the Investigator based on a medical evaluation (including a physical examination, medical history, electrocardiogram [ECG], vital signs, concomitant medication and the results of laboratory safety tests) performed during the screening visit.
- Participants with T2DM may be enrolled if they have/are: a. Hemoglobin A1c ≤11% at screening b. On a stable regimen for at least 8 weeks prior to screening, defined as: stable diet and exercise program, and/or, stable dose of metformin, and/or, stable dose of a sodium-glucose cotransporter-2 inhibitor.
Exclusion Criteria:
All participants:
- Known or suspected hypersensitivity to the IMP or related products.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Petrelintide: Normal Hepatic Function
Participants with normal hepatic function will receive a single SC dose of petrelintide.
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Petrelintide will be administered as a single SC injection.
Outros nomes:
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Experimental: Petrelintide: Mild HI
Participants with mild HI will receive a single SC dose of petrelintide.
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Petrelintide will be administered as a single SC injection.
Outros nomes:
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Experimental: Petrelintide: Moderate HI
Participants with moderate HI will receive a single SC dose of petrelintide.
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Petrelintide will be administered as a single SC injection.
Outros nomes:
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Experimental: Petrelintide: Severe HI
Participants with severe HI will receive a single SC dose of petrelintide.
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Petrelintide will be administered as a single SC injection.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Petrelintide
Prazo: Day 1 (pre-dose) to Day 50 (Follow-up)
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Day 1 (pre-dose) to Day 50 (Follow-up)
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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AUC from Time Zero up to Time of Last Measurable Concentration (AUC0-last) of Petrelintide
Prazo: Day 1 (pre-dose) to Day 50 (Follow-up)
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Day 1 (pre-dose) to Day 50 (Follow-up)
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Maximum Observed Plasma Concentration (Cmax) of Petrelintide
Prazo: Day 1 (pre-dose) to Day 50 (Follow-up)
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Day 1 (pre-dose) to Day 50 (Follow-up)
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Time to Cmax (tmax)
Prazo: Day 1 (pre-dose) to Day 50 (Follow-up)
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Day 1 (pre-dose) to Day 50 (Follow-up)
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Apparent Clearance (CL/F) of Petrelintide
Prazo: Day 1 (pre-dose) to Day 50 (Follow-up)
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Day 1 (pre-dose) to Day 50 (Follow-up)
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Terminal Elimination Half-life (t1/2) of Petrelintide
Prazo: Day 1 (pre-dose) to Day 50 (Follow-up)
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Day 1 (pre-dose) to Day 50 (Follow-up)
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Apparent Volume of Distribution at Terminal Phase (Vz/F) of Petrelintide
Prazo: Day 1 (pre-dose) to Day 50 (Follow-up)
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Day 1 (pre-dose) to Day 50 (Follow-up)
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Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Prazo: Day 1 up to Day 50
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Day 1 up to Day 50
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Clinical Trial Information Desk, Zealand Pharma 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
Palavras-chave
Outros números de identificação do estudo
- ZP8396-25077
- Universal Trial number (Outro identificador: U1111-1328-8578)
- 2025-523641-10-00 (Ctis)
Plano para dados de participantes individuais (IPD)
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