A Study to Learn How the Body Processes the Study Medicine Called Vepdegestrant in People With Loss of Liver Function

Официальное название

A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF VEPDEGESTRANT (PF-07850327) IN ADULT PARTICIPANTS WITH MODERATE AND SEVERE HEPATIC IMPAIRMENT RELATIVE TO HEALTHY PARTICIPANTS WITH NORMAL HEPATIC FUNCTION

Обзор

The purpose of the study is to look at how the body processes a study medicine called vepdegestrant in participants with loss of liver function relative to people with normal liver function. This study is seeking participants who are: * females who cannot have children or males * between 18 and 70 years of age * weigh more than 50 Kilograms (110 pounds) * either healthy with normal liver function or have loss of liver function All participants in this study will take one dose of vepdegestrant by mouth. This study looks at how the medicine is changed and removed from the body after being taken by the participants. The amount of vepdegestrant in participants with loss of liver function will be compared to the amount of vepdegestrant in participants with normal liver function. All participants will stay at the study clinic for about 11 days and 10 nights.

Вмешательства

• Препарат vepdegestrant
  Vepdegestrant administered as a single oral 200 mg dose

Первичные конечные точки

• Maximum observed concentration (Cmax) for vepdegestrant [Срок оценки: Pre-dose, and 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, and 216 hours post dose]
• Area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] for vepdegestrant [Срок оценки: Pre-dose, and 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, and 216 hours post dose]

Вторичные конечные точки (4)

• Number of Participants With Treatment-Emergent Adverse Events [Срок оценки: Time from baseline through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.]
• Number of Participants With Clinically Significant Clinical Laboratory Abnormalities [Срок оценки: Time from baseline through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.]
• Number of Participants With Clinically Significant Change From Baseline in Vital Signs [Срок оценки: Time from baseline through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.]
• Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities [Срок оценки: Time from baseline through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.]

Критерии участия

Inclusion criteria including but not limited to:

• Female participants of non-childbearing potential, or male participants between the age of 18 years (or the minimum age of consent in accordance with local regulations) and 70 years, inclusive, at screening.
• Body mass index of 17.5-38 kg/m2, inclusive, and a total body weight >50 kg (110 lb).

Normal hepatic function group only:

-Overtly healthy as determined by medical evaluations including medical history, physical examination, laboratory tests, vital signs and standard 12-lead ECGs.

Hepatic impairment groups only:

• Satisfy the criteria for Class B (Group 2: moderate hepatic impairment) or C (Group 3: severe hepatic impairment) of the modified Child-Pugh Classification.
• Stable hepatic impairment, defined as no clinically significant change in disease status within the last 28 days prior to the screening visit, as documented by the participant's recent medical history.

Exclusion criteria including but not limited to:

• Any condition possibly affecting drug absorption.
• Use of prohibited prior or concomitant medications.

Normal hepatic function group only:

-Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Hepatic impairment groups only:

-A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, PE, liver biopsy, hepatic ultrasound, CT scan, or MRI.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 4 центра

• Clinical Pharmacology of Miami — Miami
• Floridian Clinical Research, LLC — Miami Lakes
• Orlando Clinical Research Center — Orlando
• Genesis Clinical Research, LLC — Tampa

Идентификаторы

NCT: NCT07231991 · C4891004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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