- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07721402
A Study to Learn About How Different Forms of Study Medicine Prifetrastat Are Taken Up Into the Blood in Healthy Adults
A PHASE 1, RANDOMIZED, OPEN-LABEL, 2-PERIOD, 4-SEQUENCE SINGLE-DOSE CROSSOVER STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE RELATIVE BIOAVAILABILITY OF PRIFETRISTAT DRUG PRODUCT DIFFERING IN PARTICLE SIZE DISTRIBUTION
The purpose of this study is to understand the relative amount of drug that enters bloodstream from prifetrastat product lots differing in active ingredient particle size distribution.
The study is seeking participants who are:
Healthy males and females of non-childbearing potential >=18 years of age at screening
Participants in the study will receive a single dose of prifetrastat by mouth. After at least 14 days, they will receive another dose of prifetrastat by mouth. Each dose received by the patient will be in tablet form. The sequence in which tablets are given will be random.
The study will help understand how the difference in particle size distributions of the tablets may, or may not, affect how the drug is absorbed, processed, and eliminated by the body.
Participants will remain in the study clinic for 21 days. However, they may be permitted to leave between periods, and will have one follow-up contact.
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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Bruxelles-capitale, Région de
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Brussels, Bruxelles-capitale, Région de, Bélgica, B-1070
- Recrutamento
- Pfizer Clinical Research Unit - Brussels
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion
- Females of non-childbearing potential and males >=18 years of age at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.
- BMI of 18-32 kilogram per meter square(Kg/m^2); and a total body weight >50 kg (110 lb).
Exclusion
- Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention
- Prior use of epigenetic modifying agents. Participants will only be permitted to enroll in a single arm of this study (cannot participate in Arm 1 and Arm 2).
- Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
- current use or anticipated need for food or drugs that are known strong inducers or inhibitors of CYP2C9 or CYP3A4, including their administration within 14 days plus 5 half-lives of the strong inducers or inhibitors of CYP2C9 or CYP3A4, whichever is longer, prior to first dose of study intervention, during the treatment period, and within 2 days after the last dose of prifetrastat
- Proton pump inhibitors must be discontinued at least 14 days prior to the first dose of study medication and throughout treatment period.
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 |
|---|---|
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Comparador Ativo: Arm 1 prifetrastat
Crossover
|
Reference Treatment
Test 1 Treatment
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|
Comparador Ativo: Arm 2 prifetrastat
Crossover
|
Reference Treatment
Test 2 Treatment
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Area under the Plasma Concentration-Time profile from time 0 to extrapolated infinite time (AUCinf) of Reference treatment of prifetrastat (AUClast If data does not permit AUCinf)
Prazo: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
AUCinf was area under the plasma concentration time-curve from zero (pre-dose) extrapolated out to infinite time (If data permits).
|
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
|
Maximum Observed Plasma Concentration (Cmax) profile of Reference prifetrastat treatment
Prazo: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
Cmax was the maximum observed plasma concentration directly observed from data.
|
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
|
Area under the Plasma Concentration-Time profile from time 0 to extrapolated infinite time (AUCinf) of Test 1 treatment of prifetrastat (AUClast If data does not permit AUCinf)
Prazo: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
AUCinf was area under the plasma concentration time-curve from zero (pre-dose) extrapolated out to infinite time (If data permits).
|
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
|
Maximum Observed Plasma Concentration (Cmax) profile of Test 1 prifetrastat treatment
Prazo: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
Cmax was the maximum observed plasma concentration directly observed from data.
|
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
|
Area under the Plasma Concentration-Time profile from time 0 to extrapolated infinite time (AUCinf) of Test 2 treatment of prifetrastat (AUClast If data does not permit AUCinf)
Prazo: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
AUCinf was area under the plasma concentration time-curve from zero (pre-dose) extrapolated out to infinite time (If data permits).
|
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
|
Maximum Observed Plasma Concentration (Cmax) profile of Test 2 prifetrastat treatment
Prazo: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
Cmax was the maximum observed plasma concentration directly observed from data.
|
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Prazo: Up to Day 35 after the last dose of study intervention in Period 2
|
Up to Day 35 after the last dose of study intervention in Period 2
|
|
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Prazo: Up to Day 35 after the last dose of study intervention in Period 2
|
Up to Day 35 after the last dose of study intervention in Period 2
|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Prazo: Up to Day 35 after the last dose of study intervention in Period 2
|
Up to Day 35 after the last dose of study intervention in Period 2
|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Prazo: Up to Day 35 after the last dose of study intervention in Period 2
|
Up to Day 35 after the last dose of study intervention in Period 2
|
|
Number of Participants With Clinically Significant Physical Examination Abnormalities
Prazo: Up to Day 35 after the last dose of study intervention in Period 2
|
Up to Day 35 after the last dose of study intervention in Period 2
|
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
Palavras-chave
Outros números de identificação do estudo
- C4551017
- 2026-526038-26-00 (Identificador de registro: CTIS (EU))
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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