A Study to Learn How the Study Medicine Called Atirmociclib is Handled by the Body in People With Normal Liver Function and Different Levels of Liver Disease

Официальное название

A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF ATIRMOCICLIB IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITH NORMAL HEPATIC FUNCTION

Обзор

The purpose of this study to understand how the study medicine atirmociclib behaves in the body and how safe it is for people with different levels of liver health. The study is seeking participants who are: * Aged 18 years or older * Have a BMI of 17.5 to 40 kg/m2, and body weight more than 50 kg. * Have normal liver function or have stable mild, moderate, or severe liver disease Participants will receive study medicine by mouth. Blood samples will be collected to see how much of the medicine is in the body over time. This will help understand whether liver disease changes how the medicine is handled. Participants will be in the study for about 9 weeks. Those with normal liver function will stay in the clinic for about 7 days. People with liver disease will stay for about 9 days. After leaving the clinic, people may be contacted for follow-up. This may be done by phone or through a clinic visit.

Вмешательства

• Препарат Atirmociclib
  atirmociclib administered as a single oral dose

Первичные конечные точки

• Maximum Observed Plasma Concentration (Cmax) for atirmociclib in participants with normal hepatic function [Срок оценки: Pre-dose and at, 1, 2, 4, 6, 8, 12, and 24, 36, 48, 60, 72, 96, 120, 144 hours after a single oral dose]
• Maximum Observed Plasma Concentration (Cmax) for atirmociclib in participants with hepatic impairment [Срок оценки: Pre-dose and at, 1, 2, 4, 6, 8, 12, and 24, 36, 48, 60, 72, 96, 120, 144, 168, 192 hours after a single oral dose]
• Area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] for atirmociclib in participants with normal hepatic function [Срок оценки: Pre-dose and at, 1, 2, 4, 6, 8, 12, and 24, 36, 48, 60, 72, 96, 120, 144 hours after a single oral dose]
• Area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] for atirmociclib in participants with impaired hepatic function [Срок оценки: Pre-dose and at, 1, 2, 4, 6, 8, 12, and 24, 36, 48, 60, 72, 96, 120, 144, 168, 192 hours after a single oral dose]

Вторичные конечные точки (7)

• 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 atirmociclib]
• Number of Participants With Normal Hepatic Function having Clinically Significant Clinical Laboratory Abnormalities [Срок оценки: Baseline and Day 2, Day 7 after a single oral dose of atirmociclib]
• Number of Participants With Impaired Hepatic Function having Clinically Significant Clinical Laboratory Abnormalities [Срок оценки: Baseline and Day 2, Day 9 after a single oral dose of atirmociclib]
• Number of Participants With Normal Hepatic Function having Clinically Significant Change From Baseline in Vital Signs [Срок оценки: Predose and at 4, 144 hours after a single oral dose of atirmociclib]
• Number of Participants With Impaired Hepatic function having Clinically Significant Change From Baseline in Vital Signs [Срок оценки: Predose and at 4, 192 hours after a single oral dose of atirmociclib]
• Number of Participants With Normal Hepatic Function having Clinically Significant Electrocardiogram (ECG) Abnormalities [Срок оценки: Predose and at 4, 144 hours after a single oral dose of atirmociclib]
• Number of Participants With Impaired Hepatic Function having Clinically Significant Electrocardiogram (ECG) Abnormalities [Срок оценки: Predose and at 4, 192 hours after a single oral dose of atirmociclib]

Критерии участия

Inclusion criteria including but not limited to:

• BMI of 17.5-40 kg/m2; and a total body weight >50 kg (110 lb).
• Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• Capable of giving signed informed consent.

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:

\- Stable hepatic impairment meeting the criteria for Child-Pugh Class A, B, or C . Stable hepatic impairment is 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 or history of surgery 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, 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

Не применимо

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 3 центра

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

Идентификаторы

NCT: NCT07677358 · C4391014

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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