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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07715149

Enrollment

Registered

2026-07-20

Start date

2026-07-14

Completion date

2026-11-30

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult Participants, Hepatic Impairment (HI)

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.

Detailed description

This is a single-center, non-randomized, open-label, parallel-controlled study designed to evaluate the pharmacokinetic profile and safety of D-2570 in participants with hepatic impairment and those with normal hepatic function. Participants with hepatic impairment will be enrolled first, followed by participants with normal hepatic function.

Interventions

DRUGD-2570

D-2570 tablet, administered orally as a single dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
The main PK parameters -Time to maximum measured plasma concentration -Tmax Population pharmacokinetic characteristics of D-2570	Up to 192 hours after the last dose	The main PK parameters -Time to maximum measured plasma concentration -Tmax
Maximum observed plasma concentration-Cmax	Up to 192 hours after the last dose	Maximum observed plasma concentration-Cmax
The main PK parameters Half-life -t1/2	Up to 192 hours after the last dose	The main PK parameters Half-life -t1/2
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#Area under the plasma concentration versus time curve-AUC
The main PK parameters-CL/F (apparent clearance)	Up to 192 hours after the last dose	The main PK parameters-CL/F (apparent clearance)
The main PK parameters-Vz/F (apparent volume of distribution)	Up to 192 hours after the last dose	The main PK parameters-Vz/F (apparent volume of distribution)

Secondary

Measure	Time frame	Description
Incidence of adverse events	Up to Day9	Incidence of adverse events

Countries

China

Contacts

CONTACTHuan Zhou

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

PRINCIPAL_INVESTIGATORHuan Zhou

The First Affiliated Hospital of Bengbu Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026