A Pharmacokinetic Study of D-2570 in Participants With Hepatic Impairment and Normal Hepatic Function

NCT07715149 | Recruiting Phase 1

• 1 other identifier: D2570-106
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, non-randomized, open-label, parallel-group study. It will test D-2570 in people with liver problems and in people with healthy livers, to see how the drug moves through the body and whether it is safe.

Conditions

Healthy Adult Participants; Hepatic Impairment (HI)

Outcome Measures

Primary Outcomes (6)

• The main PK parameters -Time to maximum measured plasma concentration -Tmax Population pharmacokinetic characteristics of D-2570

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

  Up to 192 hours after the last dose

• Maximum observed plasma concentration-Cmax

  Maximum observed plasma concentration-Cmax

  Up to 192 hours after the last dose

• The main PK parameters Half-life -t1/2

  The main PK parameters Half-life -t1/2

  Up to 192 hours after the last dose

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

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

  Up to 192 hours after the last dose

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

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

  Up to 192 hours after the last dose

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

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

  Up to 192 hours after the last dose

Secondary Outcomes (1)

• Incidence of adverse events

  Up to Day9

Study Arms (3)

D-2570 Group 1

EXPERIMENTAL

D-2570 Group 1

Drug: D-2570

D-2570 Group 2

EXPERIMENTAL

D-2570 Group 2

Drug: D-2570

D-2570 Group 3

EXPERIMENTAL

D-2570 Group 3

Drug: D-2570

Interventions

D-2570 DRUG

D-2570 tablet, administered orally as a single dose

D-2570 Group 1; D-2570 Group 2; D-2570 Group 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in this study and sign the written informed consent form after full informed consent, and agree to comply with the procedures specified in the study protocol.
• Aged 18 to 70 years.
• Both males and females are eligible.
• Male participants must weigh no less than 50 kg, and female participants must weigh no less than 45 kg.
• Participants with normal hepatic function must have adequate hematologic, renal, and hepatic function.
• Have no plan to reproduce or donate sperm/eggs from screening until 30 days after the last dose of study drug, and agree to either completely abstain from sexual intercourse or use effective contraceptive measures from screening until 30 days after the last dose of study drug, as detailed in Appendix 3.

You may not qualify if:

• Have undergone any prior surgery that may affect drug absorption, distribution, metabolism, or excretion, which, in the opinion of the investigator, would make the participant unsuitable for enrollment.
• Are female and currently lactating, or have a positive serum pregnancy test result at screening or during the study period.
• Have a known history of drug or substance abuse, or test positive for drugs of abuse on the urine drug screen.
• Have participated in another interventional clinical trial within 3 months prior to screening, or are currently participating in another clinical trial (participants who withdraw from a prior trial before treatment, i.e., were not randomized or did not receive study intervention, may be enrolled in this study).
• Have received a live vaccine within 2 months prior to study drug administration, or intend to receive a live vaccine during the study period.
• Have any other condition or finding that, in the opinion of the investigator, would make the participant unsuitable for participation in this study.

Sponsors & Collaborators

• InventisBio Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, 233004, China

RECRUITING

Study Officials

• Huan Zhou

  The First Affiliated Hospital of Bengbu Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huan Zhou

CONTACT

+86 0552-3085747; zhouhuanbest@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 20, 2026
• Study Start: July 14, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

CN (1)