A Study to Learn How Different Forms of the Study Medicine Called PF-08049820 Are Absorbed and Eliminated in Healthy Adults
A PHASE 1, OPEN-LABEL, RANDOMIZED, 5-PERIOD, 6-SEQUENCE, CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF ONE IMMEDIATE RELEASE AND TWO MODIFIED-RELEASE FORMULATIONS OF PF-08049820 ADMINISTERED ORALLY UNDER FASTED AND FED CONDITIONS (PART A), AND A FIXED SEQUENCE STUDY TO ASSESS THE EFFECT OF RABEPRAZOLE ON THE PHARMACOKINETICS OF PF-08049820 (PART B), IN HEALTHY ADULTS
The purpose of this study is to learn how different forms of the study medicine called PF-08049820 are absorbed and eliminated in healthy adults. The study will assess whether the study medicine is absorbed differently when taken with or without food. It will also assess absorption when the study medicine is taken with another medicine called rabeprazole. Rabeprazole is an FDA approved medicine that reduces stomach acid.
The study has two parts. In Part A, participants will take three forms of study medicine, one after the other. They will take each form either with or without food for a total of five doses. Each dose will be separated by a few days. Participants will stay in the clinic for about two weeks. They will receive a telephone follow-up call about a month after the last dose.
In Part B, participants will take three forms of study medicine. They will take each one with or without food, and with or without another medicine called rabeprazole. This means they will take a total of six doses of study medicine. Each dose will be separated by a few days. Participants will stay at the clinic for about three weeks, and about a month after their last dose. They will get a follow-up phone call. Part B may or may not be conducted depending on the results from Part A.
The study is seeking participants who:
- Are males or females,
- Are at least 18 years of age,
- Have a body mass index (BMI) 16 to 32 kilograms per meter squared (kg/m2). Have a total body weight of more than 50 kilograms (kg) (110 pounds).
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Pfizer CT.gov Call Center
- Número de telefone: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Locais de estudo
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06511
- Recrutamento
- Pfizer Clinical Research Unit - New Haven
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Healthy males and females.
- At least 18 years of age
- Body mass index (BMI) of 16-32 kg/m2; and a total body weight >50kg (110 lb.).
Exclusion Criteria:
- Evidence or history of clinically significant medical conditions.
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B or hepatitis C.
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
- Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Sequence 1 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
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Administrado por via oral
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Experimental: Sequence 2 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
|
Administrado por via oral
|
|
Experimental: Sequence 3 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
|
Administrado por via oral
|
|
Experimental: Sequence 4 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
|
Administrado por via oral
|
|
Experimental: Sequence 5 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
|
Administrado por via oral
|
|
Experimental: Sequence 6 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
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Administrado por via oral
|
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Experimental: Sequence 7 (Optional Part B)
3 different formulations of PF-08049820 administered orally with or without rabeprazole under fasted or fed conditions.
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Administrado por via oral
Administered orally
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Prazo: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
Part A: Evaluate the relative bioavailability of different formulations of PF-08049820. Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820. |
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
|
Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit
Prazo: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
Part A: Evaluate the relative bioavailability of 3 different formulations of PF-08049820. Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820. |
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
|
Maximum observed plasma concentration (Cmax)
Prazo: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
Part A: Evaluate the relative bioavailability of 3 different formulations of PF-08049820. Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820. |
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Prazo: Baseline up to Day 48 for Part A and up to Day 56 for optional Part B
|
Part A and optional Part B
|
Baseline up to Day 48 for Part A and up to Day 56 for optional Part B
|
|
Number of Participants With Serious Adverse Events (SAEs)
Prazo: Baseline up to Day 48 for Part A and up to Day 56 for optional Part B
|
Part A and optional Part B
|
Baseline up to Day 48 for Part A and up to Day 56 for optional Part B
|
|
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Prazo: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
Part A and optional Part B
|
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Prazo: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
Part A and optional Part B
|
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
|
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Prazo: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
Part A and optional Part B
|
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
|
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Prazo: Baseline up to Day 16 for Part A
|
Part A only: Evaluate the food effect on the PK of different formulations of PF-08049820.
|
Baseline up to Day 16 for Part A
|
|
Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit
Prazo: Baseline up to Day 16 for Part A
|
Part A only: Evaluate the food effect on the PK of different formulations of PF-08049820.
|
Baseline up to Day 16 for Part A
|
|
Maximum observed plasma concentration (Cmax)
Prazo: Baseline up to Day 16 for Part A
|
Part A only: Evaluate the food effect on the PK of different formulations of PF-08049820.
|
Baseline up to Day 16 for Part A
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Pfizer CT.gov Call Center, Pfizer
Publicações e links úteis
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
- C6231008
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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