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Идёт набор NCT07597928

A Study to Learn How Different Forms of the Study Medicine Called PF-08049820 Are Absorbed and Eliminated in Healthy Adults

Фаза I С лечением Healthy Adults Healthy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: PF-08049820, Rabeprazole.
Кому может быть актуально
Состояния в реестре: Healthy Adults, Healthy. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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: 1. Are males or females, 2. Are at least 18 years of age, 3. 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).

Вмешательства

  • Препарат PF-08049820
    Administered orally
  • Препарат Rabeprazole
    Administered orally

Первичные конечные точки

  • Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) [Срок оценки: 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 [Срок оценки: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B]
  • Maximum observed plasma concentration (Cmax) [Срок оценки: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B]
Вторичные конечные точки (8)
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: Baseline up to Day 16 for Part A]
  • Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit [Срок оценки: Baseline up to Day 16 for Part A]
  • Maximum observed plasma concentration (Cmax) [Срок оценки: Baseline up to Day 16 for Part A]

Критерии участия

Критерии включения

  • 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.).

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Pfizer Clinical Research Unit - New Haven — New Haven

Идентификаторы

NCT: NCT07597928 · C6231008

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗