A Study to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-58067 in Healthy Participants
An Open-Label, Parallel Group Study Designed to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-58067 in Healthy Participants
This study is being done to understand how the body processes the study drug (BGB-58067) when it is taken together with other medicines.
BGB-58067 is mainly broken down in the body by a liver enzyme called CYP3A. Some medicines can affect how this enzyme works. For example, certain medicines can increase the production of the enzyme (called inducers), while others can block or inhibit its activity (called inhibitors). This may change how much of the study drug is present in the bloodstream.
In this study, we will give BGB-58067 together with two commonly used medicines:
- Part A: Phenytoin (inducer), which can increase the production of the enzyme, and
- Part B: Itraconazole (inhibitor), which can inhibit the activity of the enzyme.
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Tipo de estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Estágio
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
Contato de estudo
- Nome: Study Director
- Número de telefone: 1-877-828-5568
- E-mail: clinicaltrials@beonemed.com
Locais de estudo
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South Australia
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Adelaide, South Australia, Austrália, SA 5000
- Recrutamento
- CMAX Clinical Research
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Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Participants must sign the Informed Consent Form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- Participants must be willing and able to comply with all study requirements.
Participants who are overtly healthy as determined by medical evaluation including medical history, clinical laboratory assessments, vital sign measurements,12-lead electrocardiogram (ECG), and physical examination at screening and check-in as determined by the investigator, with additional requirements as follows:
a. Body Mass Index (BMI) of 18.0 to 32.0 kg/m2 inclusive.
- Female participants must be of no childbearing potential. Note: A female participant is considered of childbearing potential (ie, fertile, following menarche, and until becoming postmenopausal) unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy
- Nonsterile male participants must be willing to use condom and refrain from sperm donation for the duration of the study and for 3 months after the last dose of BGB-58067. An additional highly effective method of birth control is highly recommended for the duration of the study and for 3 months after the last dose of BGB-58067. A sterile man is defined as one for whom azoospermia has been previously demonstrated in a semen sample examination as definitive evidence of infertility. Men with known "low sperm counts" (consistent with "subfertility") are not to be considered sterile for purposes of this study
Exclusion Criteria:
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- Presence or history of relevant seasonal allergies requiring treatment, drug and/or food allergies (ie, allergy to any study drug or excipients, or any significant food allergy that could preclude a standard diet in the study site). Hay fever is not an exclusion criterion unless it is active
- Significant serious skin disease as judged by the investigator, including rash, food allergy, eczema, psoriasis, or urticaria
- History of clinically significant cardiovascular, hematological, renal, hepatic, chronic respiratory, or gastrointestinal (GI) disease; neurological or psychiatric (including suicidal ideation or behavior) disorder; or severe cutaneous adverse reactions (SCAR) such as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), as judged by the investigator.
- Participants with a history of cholecystectomy or gall stones
- Poor venous access that limits phlebotomy
- Positive highly sensitive serum pregnancy test at screening, and positive highly sensitive urine test at admission.
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
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)
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
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Experimental: Part A: BGB-58067 + Phenytoin (CYP3A Inducer)
Participants will receive BGB-58067 on Day 1 and Day 18 and phenytoin on Days 4 to 20.
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Administrado por via oral
Administered orally
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Experimental: Part B: BGB-58067 + Itraconazole (CYP3A Inhibitor)
Participants will receive BGB-58067 on Days 1 and 8 and itraconazole on Days 4 to 11.
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Administrado por via oral
Administered orally
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O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Part A and Part B: Time of the Maximum Observed Concentration (Tmax) of BGB-58067
Prazo: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A and Part B: Maximum Observed Concentration (Cmax) of BGB-58067
Prazo: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A and Part B: Area Under the Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of BGB-58067
Prazo: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A and Part B: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-58067
Prazo: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A and Part B: Apparent Terminal Elimination Half-life (t1/2) of BGB-58067
Prazo: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A and Part B: Apparent Total Clearance (CL/F) of BGB-58067
Prazo: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A and Part B: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BGB-58067
Prazo: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Part A and Part B: Number of Participants with Adverse Events (AEs)
Prazo: Up to approximately 30 days
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Safety will be assessed by monitoring and recording of all treatment emergent adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v6.0
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Up to approximately 30 days
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Diretor de estudo: Study Director, BeOne Medicines
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- BGB-58067-102
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
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Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
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