The Study is to Investigate D-2570 in Participants With Different Levels of Kidney Function.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: D-2570.
- Who it may be relevant to
- Registry conditions: Renal Impairment. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Study to Evaluate the Pharmacokinetics of D-2570 in Participants With Renal Impairment Compared to Those With Normal Renal Function
Overview
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.
Detailed description
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.
Interventions
- Drug D-2570
receive a single dose of D-2570
Primary outcome measures
- The main PK parameters -Time to maximum measured plasma concentration -Tmax [Time frame: Through study completion (approximately Day9)]
- Maximum observed plasma concentration-Cmax [Time frame: Through study completion (approximately Day9)]
- The main PK parameters Half-life -t1/2 [Time frame: Through study completion (approximately Day9)]
- The main PK parameters#Area under the plasma concentration versus time curve-AUC [Time frame: Through study completion (approximately Day9)]
- The main PK parameters-CL/F (apparent clearance) [Time frame: Through study completion (approximately Day9)]
- The main PK parameters-Vz/F (apparent volume of distribution) [Time frame: Through study completion (approximately Day9)]
- The cumulative excretion amount (Aeu) [Time frame: Through study completion (approximately Day9)]
- The fraction of drug excreted in urine (Feu) [Time frame: Through study completion (approximately Day9)]
- The renal clearance rate (CLR) [Time frame: Through study completion (approximately Day9)]
Secondary outcome measures (1)
- Number of participants with treatment-related adverse events as assessed by CTCAE v6.0 [Time frame: Through study completion (approximately Day9)]
Eligibility criteria
Inclusion criteria
- 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;
Exclusion criteria
- 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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
China · 1 center
- The First Affiliated Hospital of Anhui Medical University — Hefei
Identifiers
NCT: NCT07715175 · D2570-107 · CTR20261754