Comparative PK Assessment Study of Casdatifan in Moderate Hepatically Impaired Participants Versus Matched Participants With Normal Hepatic Function

Официальное название

A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Pharmacokinetics of Casdatifan (AB521) in Participants With Moderate Hepatic Impairment Compared to Healthy Matched Participants

Обзор

The purpose of the study is to compare the single dose PK of casdatifan between participants with moderate hepatic impairment (HI) and healthy matched control participants with normal hepatic function.

Вмешательства

• Препарат Casdatifan
  Participants will receive a 100 mg single oral dose of casdatifan.

Первичные конечные точки

• Area under the concentration time curve, from time 0 to the last observed non-zero concentration, of casdatifan in plasma (AUC0-t) [Срок оценки: Up to 10 days post-dose]
• Area under the concentration time curve from time 0 extrapolated to infinity of casdatifan in plasma (AUC0-inf) [Срок оценки: Up to 10 days post-dose]
• Maximum observed concentration of casdatifan in plasma (Cmax) [Срок оценки: Up to 10 days post-dose]

Вторичные конечные точки (8)

• Time to reach Cmax of casdatifan in plasma (Tmax) [Срок оценки: Up to 10 days post-dose]
• Apparent first order terminal elimination rate constant calculated from a semi log plot of the plasma concentration versus time curve (Kel) [Срок оценки: Up to 10 days post-dose]
• Percent of AUC0-inf extrapolated (AUC%extrap) [Срок оценки: Up to 10 days post-dose]
• Apparent first order terminal elimination half life (t½) [Срок оценки: Up to 10 days post-dose]
• Apparent total clearance (CL/F) [Срок оценки: Up to 10 days post-dose]
• Apparent total clearance (Vz/F) [Срок оценки: Up to 10 days post-dose]
• Unbound fraction (fu) of casdatifan [Срок оценки: Up to 10 days post-dose]
• Number of participants experiencing Adverse Events (AEs) [Срок оценки: Up to 23 days post-dose]

Критерии участия

Критерии включения

All Participants:

• Male participants must be vasectomized
• BMI ≥ 18.0 and ≤ 42.0 kg/m2 and body weight ≥ 45 kg at screening.

Participants with Moderate HI (Group 1)

• Is classified as having moderate HI by the Child-Pugh classification system (Class B, score of 7 to 9, inclusive) at screening.
• Has a diagnosis of chronic (> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency at screening

Healthy Participants:

• Healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs, as deemed by the PI or designee

Критерии исключения

All Participants:

• Participants with Gilbert's syndrome.

Participants with Moderate HI (Group 1):

• Positive for HBsAg or HCV Ab, and detectable viral load at screening.
• Severe complications of liver disease within the preceding 3 months of screening.
• Fluctuating or rapidly deteriorating hepatic function from screening until prior to dosing, in the opinion of the PI or designee.

Healthy Control Participants:

• History or presence of clinically significant medical or psychiatric condition or disease, or presence of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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

Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07751250 · ARC-521-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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