A Pharmacokinetic Study of D-2570 in Participants With Hepatic Impairment and Normal Hepatic Function

Обзор

This is a single-center, non-randomized, open-label, parallel-group study. It will test D-2570 in people with liver problems and in people with healthy livers, to see how the drug moves through the body and whether it is safe.

Подробное описание

This is a single-center, non-randomized, open-label, parallel-controlled study designed to evaluate the pharmacokinetic profile and safety of D-2570 in participants with hepatic impairment and those with normal hepatic function. Participants with hepatic impairment will be enrolled first, followed by participants with normal hepatic function.

Вмешательства

• Препарат D-2570
  D-2570 tablet, administered orally as a single dose

Первичные конечные точки

• The main PK parameters -Time to maximum measured plasma concentration -Tmax Population pharmacokinetic characteristics of D-2570 [Срок оценки: Up to 192 hours after the last dose]
• Maximum observed plasma concentration-Cmax [Срок оценки: Up to 192 hours after the last dose]
• The main PK parameters Half-life -t1/2 [Срок оценки: Up to 192 hours after the last dose]
• The main PK parameters#Area under the plasma concentration versus time curve-AUC [Срок оценки: Up to 192 hours after the last dose]
• The main PK parameters-CL/F (apparent clearance) [Срок оценки: Up to 192 hours after the last dose]
• The main PK parameters-Vz/F (apparent volume of distribution) [Срок оценки: Up to 192 hours after the last dose]

Вторичные конечные точки (1)

• Incidence of adverse events [Срок оценки: Up to Day9]

Критерии участия

Критерии включения

• Voluntarily participate in this study and sign the written informed consent form after full informed consent, and agree to comply with the procedures specified in the study protocol.
• Aged 18 to 70 years.
• Both males and females are eligible.
• Male participants must weigh no less than 50 kg, and female participants must weigh no less than 45 kg.
• Participants with normal hepatic function must have adequate hematologic, renal, and hepatic function.
• Have no plan to reproduce or donate sperm/eggs from screening until 30 days after the last dose of study drug, and agree to either completely abstain from sexual intercourse or use effective contraceptive measures from screening until 30 days after the last dose of study drug, as detailed in Appendix 3.

Критерии исключения

• Have undergone any prior surgery that may affect drug absorption, distribution, metabolism, or excretion, which, in the opinion of the investigator, would make the participant unsuitable for enrollment.
• Are female and currently lactating, or have a positive serum pregnancy test result at screening or during the study period.
• Have a known history of drug or substance abuse, or test positive for drugs of abuse on the urine drug screen.
• Have participated in another interventional clinical trial within 3 months prior to screening, or are currently participating in another clinical trial (participants who withdraw from a prior trial before treatment, i.e., were not randomized or did not receive study intervention, may be enrolled in this study).
• Have received a live vaccine within 2 months prior to study drug administration, or intend to receive a live vaccine during the study period.
• Have any other condition or finding that, in the opinion of the investigator, would make the participant unsuitable for participation in this study.

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

Китай · 1 центр

• The First Affiliated Hospital of Bengbu Medical University — Bengbu

Идентификаторы

NCT: NCT07715149 · D2570-106

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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