The Study is to Investigate D-2570 in Participants With Different Levels of Kidney Function.

Официальное название

A Study to Evaluate the Pharmacokinetics of D-2570 in Participants With Renal Impairment Compared to Those With Normal Renal Function

Обзор

This study is divided two parts into: Part A and Part B. Part A will recruit 24 research participants, and Part B will recruit 16 research participants.

Подробное описание

Subjects of this study will be admitted to the Phase I ward of the research center one day before drug administration . On the first day, subjects will orally take a single dose of D-2570. The researchers will collect a series of blood and urine samples before and after drug D - 2570 administration to determine the drug concentration and evaluate the pharmacokinetic characteristics. The subjects can leave site after completing the safety evaluation.

Вмешательства

• Препарат D-2570
  receive a single dose of D-2570

Первичные конечные точки

• The main PK parameters -Time to maximum measured plasma concentration -Tmax [Срок оценки: Through study completion (approximately Day9)]
• Maximum observed plasma concentration-Cmax [Срок оценки: Through study completion (approximately Day9)]
• The main PK parameters Half-life -t1/2 [Срок оценки: Through study completion (approximately Day9)]
• The main PK parameters#Area under the plasma concentration versus time curve-AUC [Срок оценки: Through study completion (approximately Day9)]
• The main PK parameters-CL/F (apparent clearance) [Срок оценки: Through study completion (approximately Day9)]
• The main PK parameters-Vz/F (apparent volume of distribution) [Срок оценки: Through study completion (approximately Day9)]
• The cumulative excretion amount (Aeu) [Срок оценки: Through study completion (approximately Day9)]
• The fraction of drug excreted in urine (Feu) [Срок оценки: Through study completion (approximately Day9)]
• The renal clearance rate (CLR) [Срок оценки: Through study completion (approximately Day9)]

Вторичные конечные точки (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v6.0 [Срок оценки: Through study completion (approximately Day9)]

Критерии участия

Критерии включения

• Voluntarily participate in this study after adequate informed consent, sign the written informed consent form, and agree to comply with all procedures specified in the study protocol;
• Aged 18 to 70 years (inclusive). Age matching will be conducted between the normal renal function group and the matched renal impairment group with a mean difference within ±10 years;
• Male and female participants are eligible. Gender matching will be performed between the normal renal function group and the matched renal impairment group with a difference of no more than 1 subject;
• Male participants weigh no less than 50 kg, and female participants weigh no less than 45 kg. Body mass index (BMI) = weight (kg) / height squared (m²), ranging from 19 to 30 kg/m² (inclusive). Weight matching will be conducted between the normal renal function group and the matched renal impairment group with a mean difference within ±10 kg;

Критерии исключения

• Allergic constitution (e.g., allergy to pollen, two or more types of drugs/foods), or history of atopic diseases such as asthma and urticaria, or known hypersensitivity to the study drug or its excipients;
• Positive T-SPOT result at screening. Combined with clinical signs and chest posteroanterior X-ray findings, the participant is judged by the investigator to have active pulmonary tuberculosis;

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

Китай · 1 центр

• The First Affiliated Hospital of Anhui Medical University — Хэфэй

Идентификаторы

NCT: NCT07715175 · D2570-107 · CTR20261754

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)
• NMPA/CDE CTR20261754 (платформа chinadrugtrials.org.cn)

Открыть это исследование на ClinicalTrials.gov ↗