Renal Impairment
Conditions
Keywords
Renal Impairment
Brief summary
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
DRUGD-2570
receive a single dose of D-2570
Sponsors
InventisBio Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The main PK parameters -Time to maximum measured plasma concentration -Tmax | Through study completion (approximately Day9) | The main PK parameters -Time to maximum measured plasma concentration -Tmax |
| Maximum observed plasma concentration-Cmax | Through study completion (approximately Day9) | Maximum observed plasma concentration-Cmax |
| The main PK parameters Half-life -t1/2 | Through study completion (approximately Day9) | The main PK parameters Half-life -t1/2 |
| The main PK parameters#Area under the plasma concentration versus time curve-AUC | Through study completion (approximately Day9) | The main PK parameters#Area under the plasma concentration versus time curve-AUC |
| The main PK parameters-CL/F (apparent clearance) | Through study completion (approximately Day9) | The main PK parameters-CL/F (apparent clearance) |
| The main PK parameters-Vz/F (apparent volume of distribution) | Through study completion (approximately Day9) | The main PK parameters-Vz/F (apparent volume of distribution) |
| The cumulative excretion amount (Aeu) | 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) | 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) | Through study completion (approximately Day9) | The renal clearance rate (CLR)of D - 2570 and its metabolites in urine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v6.0 | Through study completion (approximately Day9) | Incidence of adverse events |
Countries
China
Contacts
CONTACTHuan Zhou, Doctor
CONTACTDingli Yao, Bachelor's
PRINCIPAL_INVESTIGATORHuan Zhou, Doctor
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed