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Um estudo para aprender sobre o medicamento (PF-07321332 ou Nirmatrelvir/Ritonavir) em mulheres lactantes saudáveis

28 de abril de 2026 atualizado por: Pfizer

ESTUDO FARMACOCINÉTICO ABERTO DE FASE I, DOSE MÚLTIPLA DE NIRMATRELVIR/RITONAVIR EM MULHERES LACTANTES SAUDÁVEIS

O principal objetivo deste estudo é medir o nível do ingrediente ativo do medicamento do estudo (nirmatrelvir) que é secretado no leite materno humano quando administrado a mulheres lactantes saudáveis. O medicamento do estudo consiste em dois medicamentos, nirmatrelvir e ritonavir. Procuramos participantes do sexo feminino que sejam:

  • Amamentação ativa (lactação) pelo menos 12 semanas após o parto;
  • Idade entre 18 a 55 anos e não estar grávida atualmente;
  • Ter Índice de Massa Corporal (IMC): 17,5 kg/m2; e um peso corporal total > 50 kg (110 lb).

Os participantes tomarão o medicamento do estudo por via oral por um total de 3 vezes durante 2 dias (2 doses matinais e 1 dose noturna) na clínica do estudo. Coletaremos leite materno periodicamente do dia 2 ao 4 para medir o nível de nirmatrelvir e ritonavir nele. Uma chamada de acompanhamento de segurança será realizada em torno de 28 a 35 dias a partir da última dose para monitorar quaisquer reações que os participantes possam ter ao medicamento do estudo.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

8

Estágio

  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Bélgica
    • Bruxelles-capitale, Région de
      • Brussels, Bruxelles-capitale, Région de, Bélgica, B-1070
        • Pfizer Clinical Research Unit - Brussels

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 55 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Descrição

Critério de inclusão:

  • Mulheres lactantes saudáveis ​​que estão amamentando ativamente ou expressando leite materno, pelo menos 12 semanas após o parto e não grávidas atualmente entre 18 e 55 anos de idade
  • Índice de Massa Corporal (IMC): 17,5 kg/m2; e um peso corporal total > 50 kg (110 lb)
  • Os bebês de mulheres inscritas no estudo devem ser capazes de se alimentar com sucesso de uma mamadeira ou outro método alternativo de alimentação apropriado para a idade antes do início do estudo e devem ser capazes de tolerar a fórmula infantil se a mãe não tiver um suprimento de leite armazenado leite suficiente para cobrir a duração do estudo
  • Os participantes devem estar dispostos a interromper temporariamente a amamentação de seus bebês por um total de 4,5 dias (108 horas)
  • Os participantes devem estar dispostos a bombear regularmente os seios durante o estudo e extrair o leite de acordo com um cronograma projetado para manter a lactação durante o período do estudo

Critério de exclusão:

  • Resultado do teste positivo (RT-PCR) para infecção por SARS-CoV-2 no momento da triagem ou Dia -1
  • Evidência ou história de achados clinicamente significativos
  • História de doença febril ou mastite dentro de 5 dias antes da primeira dose da medicação do estudo
  • Participantes que receberam uma vacina COVID-19 dentro de 7 dias antes da triagem ou admissão, ou que serão vacinados com uma vacina COVID-19 a qualquer momento durante o período de confinamento do estudo
  • História de infecção por HIV, hepatite B ou hepatite C; teste positivo para HIV, HBsAg ou HCVAb. Vacinação contra hepatite B é permitida
  • Sinais vitais anormais, como pressão arterial, eletrocardiograma de 12 derivações
  • História de abuso de álcool e/ou uso de drogas ilícitas, uso de tabaco em excesso de 5 cigarros/dia ou 2 mastigações/dia
  • Doação de sangue em até 60 dias

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: nirmatrelvir/ritonavir
nirmatrelvir/ritonavir será administrado por via oral duas vezes ao dia na forma de comprimido
Medicamento: nirmatrelvir
nirmatrelvir/ritonavir
Outros nomes:
  • PF-07321332/ritonavir
Medicamento: ritonavir
nirmatrelvir/ritonavir
Outros nomes:
  • PF-07321332/ritonavir

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
The Maximum Observed Concentration of Nirmatrelvir in Breast Milk Over the Dosing Interval
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The maximum observed concentration and was directly observed from data.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Time to Reach Cmax of Nirmatrelvir in Breast Milk
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Cmax was defined as maximum observed concentration of nirmatrelvir in breast milk.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Area Under the Concentration-Time Profile From Time Zero to End of Dosing Interval for Nirmatrelvir in Breast Milk
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Area under the concentration curve for nirmatrelvir in breast milk from time 0 to end of dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Terminal Half-Life of Nirmatrelvir in Breast Milk
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The time measured for the breast milk nirmatrelvir concentration to decrease by one half.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The Average Steady State Concentration of Nirmatrelvir in Breast Milk
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The average concentration across time and can be calculated by dividing AUCtau by time. AUCtau was defined area under the concentration curve from time 0 to end of dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The Amount of Nirmatrelvir Excreted in Breast Milk Over the Dosing Interval Tau
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The amount of nirmatrelvir excreted into breast milk over the dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The Percent of Amount of Nirmatrelvir Excreted in Breast Milk Over The Dosing Interval Tau
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The percent of nirmatelvir excreted in breast milk to amount of breast milk over the dosing interval .
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Breast Milk Clearance of Nirmatrelvir
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Clearance was defined as the apparent volume (Liter) of breast milk completely cleared the nirmatrelvir per hour.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
The Maximum Observed Concentration of Ritonavir in Breast Milk Observed Over the Dosing Interval
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The maximum observed concentration and was directly observed from data.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Time to Reach Cmax of Ritonavir in Breast Milk
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Cmax was defined as maximum observed concentration of ritonavir in breast milk.
At Day -1 (24 Hours Prior to Dosing on Day 1), 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Area Under the Concentration-Time Profile for Ritonavir in Breast Milk From Time Zero to End of Dosing Interval
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Area under the concentration curve for ritonavir in breast milk from time 0 to end of dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Half-Life of Ritonavir in Breast Milk
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The time measured for the breast milk ritonavir concentration to decrease by one half.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The Average Steady State Concentration of Ritonavir in Breast Milk
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The average concentration across time and can be calculated by dividing AUCtau by time. AUCtau was defined area under the concentration curve from time 0 to end of dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The Amount of Ritonavir Excreted in Breast Milk Over the Dosing Interval Tau
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The amount of ritonavir excreted into breast milk over the dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The Percent of Ritonavir Excreted in Breast Milk Over The Dosing Interval Tau
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The percent of ritonavir excreted in breast milk to amount of breast milk over the dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Breast Milk Clearance of Ritonavir
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Clearance was defined as the apparent volume (L) of breast milk completely cleared the ritonavir per hour.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The Maximum Observed Concentration of Nirmatrelvir in Plasma Observed Over the Dosing Interval
Prazo: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The maximum observed concentration and was directly observed from data.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The Maximum Observed Concentration of Ritonavir in Plasma Observed Over the Dosing Interval
Prazo: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The maximum observed concentration and was directly observed from data.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Area Under the Concentration-Time Profile for Nirmatrelvir in Plasma From Time Zero to End of Dosing Interval
Prazo: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Area under the concentration curve for nirmatrelvir in breast milk from time 0 to end of dosing interval.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Area Under the Concentration-Time Profile for Ritonavir in Plasma From Time Zero to End of Dosing Interval
Prazo: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Area under the concentration curve for ritonavir in plasma from time 0 to end of dosing interval.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Half-Life of Nirmatrelvir in Plasma
Prazo: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The time measured for the plasma nirmatrelvir concentration to decrease by one half.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Half-Life of Ritonavir in Plasma
Prazo: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The time measured for the plasma ritonavir concentration to decrease by one half.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The Minimum Plasma Concentration of Nirmatrelvir Observed Over the Dosing Interval
Prazo: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The minimum observed concentration and was directly observed from data.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The Minimum Plasma Concentration of Ritonavir Observed Over the Dosing Interval
Prazo: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The minimum observed concentration and was directly observed from data.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Time to Reach Cmax of Nirmatrelvir in Plasma
Prazo: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Cmax was defined as maximum observed concentration of nirmatrelvir in plasma.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Time to Reach Cmax of Ritonavir in Plasma
Prazo: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Cmax was defined as maximum observed concentration of ritonavir in plasma.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Apparent Clearance of Nirmatrelvir From Plasma
Prazo: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Clearance was defined as the apparent volume (L) of plasma completely cleared the nirmatrelvir per hour.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Apparent Clearance of Ritonavir From Plasma
Prazo: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Clearance was defined as the apparent volume (L) of plasma completely cleared the ritonavir per hour.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Apparent Volume of Nirmatrelvir Distribution
Prazo: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose was influenced by the fraction absorbed.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Apparent Volume of Ritonavir Distribution
Prazo: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose was influenced by the fraction absorbed.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The Average Steady State Concentration of Nirmatrelvir in Plasma
Prazo: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The average concentration across time and can be calculated by dividing AUCtau by time. AUCtau was defined area under the concentration curve from time 0 to end of dosing interval.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The Average Steady State Concentration of Ritonavir in Plasma
Prazo: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The average concentration across time and can be calculated by dividing AUCtau by time. AUCtau was defined area under the concentration curve from time 0 to end of dosing interval.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Daily (24 Hour) Amount of Nirmatrelvir Excreted in Breast Milk
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Amount of nirmatrelvir excreted in breast milk in 24 hours.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Daily (24 Hour) Amount of Ritonavir Excreted in Breast Milk
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Amount of ritonavir excreted in breast milk in 24 hours.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Milk to Plasma Ratio of Nirmatrelvir for AUCtau During Dosing Interval
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The ratio of area under the concentration-time profile for nirmatrelvir in milk to those in plasma from time zero to end of dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Milk to Plasma Ratio of Ritonavir for AUCtau During Dosing Interval
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The ratio of area under the concentration-time profile for ritonavir in milk to those in plasma from time zero to end of dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Milk to Plasma Ratio of Nirmatrelvir for Cmax During Dosing Interval
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The ratio of the maximum concentration of nirmatrelvir in breast milk to those in plasma observed over the dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Milk to Plasma Ratio of Ritonavir for Cmax During Dosing Interval
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The ratio of the maximum concentration of ritonavir in breast milk to those in plasma observed over the dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Body Weight Normalized Infant Dose (BWNID) of Nirmatrelvir in mg/kg/Day
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
BWNID = MPAUCtau * Cav * 150 mL/kg/day, where 150 mL/kg/day^2 is the standardized milk consumption for an infant. MPAUCtau: Milk to plasma ratio for AUCtau. Cav: Average concentration.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
BWNID of Ritonavir in mg/kg/Day
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
BWNID = MPAUCtau * Cav * 150 mL/kg/day, where 150 mL/kg/day^2 is the standardized milk consumption for an infant. MPAUCtau: Milk to plasma ratio for AUCtau. Cav: Average concentration.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Body Weight Normalized Maternal Dose (BWNMD) of Nirmatrelvir in mg/kg/Day
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Maternal dose in mg/day (300 mg BID = 600 mg/day for nirmatrelvir and 100 mg BID = 200 mg/day for ritonavir) / maternal weight in kg at screening.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
BWNMD of Ritonavir in mg/kg/Day
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Maternal dose in mg/day (300 mg BID = 600 mg/day for nirmatrelvir and 100 mg BID = 200 mg/day for ritonavir) / maternal weight in kg at screening.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Infant Dose Expressed As % of Body Weight Normalized Maternal Dose (BWNIDPCM) for Nirmatrelvir
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
BWNIDPCM = 100 * BWNID / BWNMD.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
BWNIDPCM for Ritonavir
Prazo: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
BWNIDPCM = 100 * BWNID / BWNMD.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Number of Participants With Treatment Emergent Adverse Events
Prazo: From the first dose of study treatment on Day 1 to up to 28 days after the last dose of study intervention on Day 2 (maximum to 30 days)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs might arise from symptoms or other complaints reported to the investigator by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative), or they might arise from clinical findings of the investigator or other healthcare providers (clinical signs, test results, etc.). TEAEs were those with initial onset or increasing in severity after the first dose of study treatment.
From the first dose of study treatment on Day 1 to up to 28 days after the last dose of study intervention on Day 2 (maximum to 30 days)
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Prazo: At Screening (Day -28 to Day -2), Day -1, and Day 4
The laboratory abnormality parameters included urinalysis: urine bilirubin (>=1), urine hemoglobin (>=1) and leukocyte esterase (>=1).
At Screening (Day -28 to Day -2), Day -1, and Day 4
Number of Participants With Vital Signs Abnormalities
Prazo: At Screening (Day -28 to Day -2), Pre-dose and 12 Hours post-dose on Day 1, Pre-dose and 48 Hours Post-dose on Day 2
Single supine blood pressure (BP), and pulse rate (PR) were performed following approximately a 5-minute rest in a supine position. BP, and PR assessments will be performed after collection of electrocardiogram (ECGs) and prior to collection of blood draws if scheduled at the same time. Vital signs abnormality included supine systolic BP <90mmHg.
At Screening (Day -28 to Day -2), Pre-dose and 12 Hours post-dose on Day 1, Pre-dose and 48 Hours Post-dose on Day 2
Number of Participants With ECG Abnormalities
Prazo: At Screening (from Day -28 to Day -2)
Standard 12-lead ECGs utilizing limb leads (with a 10 second rhythm strip) were collected. All ECG assessments were made after at least a 5-minute rest in a supine position and prior to any blood draws or vital sign measurements.
At Screening (from Day -28 to Day -2)
Number of Participants With Physical Examination Abnormalities
Prazo: At Screening (from Day -28 to Day -2) or Day -1
Physical examination included height, weight and body mass index (BMI, BMI = weight [kg] / height [m^2]) obtained for eligibility criteria. Physical examination abnormalities: BMI <17.5 kg/m^2; and a total body weight <=50 kg (110 lb).
At Screening (from Day -28 to Day -2) or Day -1

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Pfizer

Investigadores

  • Diretor de estudo: Pfizer CT.gov Call Center, Pfizer

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

12 de dezembro de 2022

Conclusão Primária (Real)

15 de dezembro de 2023

Conclusão do estudo (Real)

15 de dezembro de 2023

Datas de inscrição no estudo

Enviado pela primeira vez

28 de junho de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de junho de 2022

Primeira postagem (Real)

1 de julho de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de abril de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • C4671039
  • 2022-001020-15 (Número EudraCT)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

A Pfizer fornecerá acesso a dados de participantes não identificados individuais e documentos de estudo relacionados (por exemplo, protocolo, Plano de Análise Estatística (SAP), Relatório de Estudo Clínico (CSR)) mediante solicitação de pesquisadores qualificados e sujeito a certos critérios, condições e exceções. Mais detalhes sobre os critérios de compartilhamento de dados da Pfizer e o processo de solicitação de acesso podem ser encontrados em: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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