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NCT Number: NCT07715175

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Location contact

Huan Zhou, Doctor

CONTACT

[email protected]

13665527160

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

D-2570

Drug

receive a single dose of D-2570

Primary outcomes

  1. The main PK parameters -Time to maximum measured plasma concentration -Tmax

    Time frame: Through study completion (approximately Day9)

    The main PK parameters -Time to maximum measured plasma concentration -Tmax

  2. Maximum observed plasma concentration-Cmax

    Time frame: Through study completion (approximately Day9)

    Maximum observed plasma concentration-Cmax

  3. The main PK parameters Half-life -t1/2

    Time frame: Through study completion (approximately Day9)

    The main PK parameters Half-life -t1/2

  4. The main PK parameters#Area under the plasma concentration versus time curve-AUC

    Time frame: Through study completion (approximately Day9)

    The main PK parameters#Area under the plasma concentration versus time curve-AUC

  5. The main PK parameters-CL/F (apparent clearance)

    Time frame: Through study completion (approximately Day9)

    The main PK parameters-CL/F (apparent clearance)

  6. The main PK parameters-Vz/F (apparent volume of distribution)

    Time frame: Through study completion (approximately Day9)

    The main PK parameters-Vz/F (apparent volume of distribution)

  7. The cumulative excretion amount (Aeu)

    Time frame: Through study completion (approximately Day9)

    The cumulative excretion (Aeu) of D - 2570 and its metabolites in urine

  8. The fraction of drug excreted in urine (Feu)

    Time frame: Through study completion (approximately Day9)

    The fraction of drug excreted in urine (Feu) of D - 2570 and its metabolites in urine

  9. The renal clearance rate (CLR)

    Time frame: Through study completion (approximately Day9)

    The renal clearance rate (CLR)of D - 2570 and its metabolites in urine

Secondary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v6.0

    Time frame: Through study completion (approximately Day9)

    Incidence of adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Dingli Yao, Bachelor's

CONTACT

[email protected]

15538261075

Huan Zhou, Doctor

CONTACT

[email protected]

13665527160

Sponsors and collaborators

Lead sponsor

InventisBio Co., Ltd

Industry

Registry information

Official study title

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

Acronym: D2570-107

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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