A Study to Learn About the Medicine Called PF-08653944 in People With and Without Reduced Liver Function

Официальное название

A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-GROUP STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-08653944 IN ADULTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIRMENT

Обзор

This study is being done to learn more about an investigational medicine called PF-08653944. The goal is to understand how the body handles the medicine and to check its safety after a single dose. The study includes adults with normal liver function and adults who have mild, moderate, or severe liver problems. By comparing these groups, researchers want to understand whether liver function changes how the medicine behaves in the body. People who join the study will receive one injection of the study medicine. They will stay at the study clinic for a short time and return for follow-up visits so doctors can do blood tests, physical exams, and safety checks. This study is not expected to provide direct medical benefit to participants. The information collected will help researchers develop future treatments and understand how this medicine may be used safely in people with liver disease.

Вмешательства

• Препарат PF-08653944
  Solution for injection

Первичные конечные точки

• Pharmacokinetics (PK): Maximum observed plasma concentration (Cmax) of PF-08653944 [Срок оценки: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.]
• PK: Area under the plasma concentration (AUC) of PF-08653944 [Срок оценки: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.]

Вторичные конечные точки (1)

• Number of participants with Treatment Emergent Adverse Events (TEAEs) [Срок оценки: First dose through study completion, approximately 11 Weeks after last dose of study intervention.]

Критерии участия

Критерии включения

• Adults 18 to 75 years of age, male or female.
• BMI ≥21 kg/m² and body weight >50 kg at screening.
• Group 1 (without hepatic impairment):

• No known or suspected hepatic impairment.
• Normal liver function tests (ALT, AST, bilirubin, albumin, PT within normal limits, with protocol-specified exceptions such as Gilbert's syndrome).
• Groups 2-4 (with hepatic impairment):

• Stable hepatic impairment classified as Child-Pugh Class A (mild), B (moderate), or C (severe).
• No clinically significant worsening of hepatic status within 28 days prior to screening.
• Women of childbearing potential must not be pregnant or breastfeeding and must agree to use highly effective contraception.

Критерии исключения

• Clinically significant medical or psychiatric conditions, including recent or active suicidal ideation or behavior.
• Use of GLP-1 receptor agonists within 90 days (or 5 half-lives) prior to dosing.
• Participation in another investigational study or receipt of an investigational product within 30 days (or 5 half-lives) prior to dosing.
• For hepatic-impairment groups only:

• Hepatic carcinoma, hepatorenal syndrome, or limited life expectancy.
• Clinically active Grade 3 or 4 hepatic encephalopathy.
• Severe uncontrolled ascites, recent gastrointestinal bleeding, or history of solid organ transplant.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 3 центра

• Floridian Clinical Research — Miami Lakes
• Orlando Clinical Research Center — Orlando
• Genesis Clinical Research — Tampa

Идентификаторы

NCT: NCT07519135 · C6491009 · MET097-25-105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗