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Исследование, чтобы узнать о лекарстве (PF-07321332 или нирматрелвир/ритонавир) у здоровых кормящих женщин

28 апреля 2026 г. обновлено: Pfizer

ФАЗА I, НЕСКОЛЬКО ДОЗ, ОТКРЫТОЕ ФАРМАКОКИНЕТИЧЕСКОЕ ИССЛЕДОВАНИЕ НИРМАТРЕЛВИРА/РИТОНАВИРА У ЗДОРОВЫХ КОРМЯЩИХ ЖЕНЩИН

Основной целью данного исследования является измерение уровня активного ингредиента исследуемого препарата (нирматрелвир), который выделяется в грудное молоко человека при приеме его здоровыми кормящими женщинами. Исследуемый препарат состоит из двух препаратов: нирматрелвира и ритонавира. Мы ищем участниц женского пола, которые:

  • Активно кормите грудью (кормите грудью) не менее 12 недель после родов;
  • Возраст от 18 до 55 лет и отсутствие беременности в настоящее время;
  • Иметь индекс массы тела (ИМТ): 17,5 кг/м2; и общая масса тела> 50 кг (110 фунтов).

Участники будут принимать исследуемое лекарство перорально в общей сложности 3 раза в течение 2 дней (2 утренние дозы и 1 вечерняя доза) в исследовательской клинике. Мы будем периодически собирать грудное молоко со 2-го по 4-й день для измерения в нем уровня нирматрелвира и ритонавира. Примерно через 28–35 дней после приема последней дозы будет проведен контрольный звонок по вопросам безопасности, чтобы отслеживать любые реакции участников на исследуемое лекарство.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

8

Фаза

  • Фаза 1

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 55 лет (Взрослый)

Принимает здоровых добровольцев

Да

Описание

Критерии включения:

  • Здоровые кормящие женщины, активно кормящие грудью или сцеживающие грудное молоко, не менее 12 недель после родов и не беременные в настоящее время в возрасте от 18 до 55 лет.
  • Индекс массы тела (ИМТ): 17,5 кг/м2; и общая масса тела> 50 кг (110 фунтов)
  • Младенцы женщин, включенных в исследование, должны быть в состоянии успешно кормить из бутылочки или другого соответствующего возрасту альтернативного метода кормления до начала исследования и должны быть в состоянии переносить детскую смесь, если у матери нет запаса сохраненной груди. молока, достаточного для покрытия продолжительности исследования
  • Участники должны быть готовы временно прекратить грудное вскармливание своих младенцев в общей сложности на 4,5 дня (108 часов).
  • Участники должны быть готовы регулярно сцеживать грудь на протяжении всего исследования и сцеживать молоко в соответствии с графиком, разработанным для поддержания лактации на протяжении всего периода исследования.

Критерий исключения:

  • Положительный результат теста (ОТ-ПЦР) на инфекцию SARS-CoV-2 во время скрининга или в День -1
  • Доказательства или история клинически значимых результатов
  • Лихорадочное заболевание или мастит в анамнезе в течение 5 дней до первой дозы исследуемого препарата.
  • Участники, которые получили вакцину против COVID-19 в течение 7 дней до скрининга или госпитализации или которые должны быть вакцинированы вакциной против COVID-19 в любое время в течение периода ограничения исследования.
  • История ВИЧ-инфекции, гепатита В или гепатита С; положительный тест на ВИЧ, HBsAg или HCVAb. Прививка от гепатита В разрешена
  • Аномальные показатели жизнедеятельности, такие как артериальное давление, электрокардиограмма в 12 отведениях.
  • Злоупотребление алкоголем и/или незаконным употреблением наркотиков, употребление табака более 5 сигарет в день или 2 жевания в день
  • Сдача крови в течение 60 дней

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Другой
  • Распределение: Н/Д
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: нирматрелвир/ритонавир
нирматрелвир/ритонавир будет вводиться перорально два раза в день в виде таблеток
Лекарство: нирматрелвир
нирматрелвир/ритонавир
Другие имена:
  • PF-07321332/ритонавир
Лекарство: ритонавир
нирматрелвир/ритонавир
Другие имена:
  • PF-07321332/ритонавир

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
The Maximum Observed Concentration of Nirmatrelvir in Breast Milk Over the Dosing Interval
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
The Maximum Observed Concentration of Ritonavir in Breast Milk Observed Over the Dosing Interval
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Pfizer

Следователи

  • Директор по исследованиям: Pfizer CT.gov Call Center, Pfizer

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

12 декабря 2022 г.

Первичное завершение (Действительный)

15 декабря 2023 г.

Завершение исследования (Действительный)

15 декабря 2023 г.

Даты регистрации исследования

Первый отправленный

28 июня 2022 г.

Впервые представлено, что соответствует критериям контроля качества

28 июня 2022 г.

Первый опубликованный (Действительный)

1 июля 2022 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

1 мая 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

28 апреля 2026 г.

Последняя проверка

1 апреля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

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

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана IPD

Pfizer предоставит доступ к личным обезличенным данным участников и связанным с ними документам исследования (например, протокол, план статистического анализа (SAP), отчет о клиническом исследовании (CSR)) по запросу квалифицированных исследователей и при соблюдении определенных критериев, условий и исключений. Дополнительную информацию о критериях обмена данными Pfizer и процессе запроса доступа можно найти по адресу: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

продукт, произведенный в США и экспортированный из США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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