A Study to Evaluate the Pharmacokinetics of D-2570 in Participants With Renal Impairment Compared to Those With Normal Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Plasma concentrations of D-2570
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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;
排除标准
- •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;
研究组 & 干预措施
participants with normal renal function
Subjects will receive a single dose of D-2570
干预措施: D-2570 (Drug)
participants with Mild Renal Impairment
Subjects will receive a single dose of D-2570 (Part B)
干预措施: D-2570 (Drug)
participants with Moderate Renal Impairment
Subjects will receive a single dose of D-2570 (Part A)
干预措施: D-2570 (Drug)
participants with Severe Renal Impairment
Subjects will receive a single dose of D-2570 (Part A)
干预措施: D-2570 (Drug)
结局指标
主要结局
Plasma concentrations of D-2570
时间窗: Through study completion (approximately Day9)
The main PK parameters-CL/F (apparent clearance)
时间窗: Through study completion (approximately Day9)
The main PK parameters-CL/F (apparent clearance)
The main PK parameters#Area under the plasma concentration versus time curve-AUC
时间窗: Through study completion (approximately Day9)
The main PK parameters#Area under the plasma concentration versus time curve-AUC
The main PK parameters -Time to maximum measured plasma concentration -Tmax
时间窗: Through study completion (approximately Day9)
The main PK parameters -Time to maximum measured plasma concentration -Tmax
Maximum observed plasma concentration-Cmax
时间窗: Through study completion (approximately Day9)
Maximum observed plasma concentration-Cmax
The main PK parameters Half-life -t1/2
时间窗: Through study completion (approximately Day9)
The main PK parameters Half-life -t1/2
The main PK parameters-Vz/F (apparent volume of distribution)
时间窗: Through study completion (approximately Day9)
The main PK parameters-Vz/F (apparent volume of distribution)
The cumulative excretion amount (Aeu)
时间窗: Through study completion (approximately Day9)
The cumulative excretion (Aeu) of D - 2570 and its metabolites in urine
The fraction of drug excreted in urine (Feu)
时间窗: Through study completion (approximately Day9)
The fraction of drug excreted in urine (Feu) of D - 2570 and its metabolites in urine
The renal clearance rate (CLR)
时间窗: Through study completion (approximately Day9)
The renal clearance rate (CLR)of D - 2570 and its metabolites in urine
次要结局
- Safety of D-2570（AEs）(Through study completion (approximately Day9))
- Number of participants with treatment-related adverse events as assessed by CTCAE v6.0(Through study completion (approximately Day9))