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Recruiting NCT07715149

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

Phase I Interventional Healthy Adult Participants Hepatic Impairment (HI)

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: Healthy Adult Participants, Hepatic Impairment (HI). 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 →

Unsure about the terms? Read our patient guide →

Overview

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

  • Drug D-2570
    D-2570 tablet, administered orally as a single dose

Primary outcome measures

  • The main PK parameters -Time to maximum measured plasma concentration -Tmax Population pharmacokinetic characteristics of D-2570 [Time frame: Up to 192 hours after the last dose]
  • Maximum observed plasma concentration-Cmax [Time frame: Up to 192 hours after the last dose]
  • The main PK parameters Half-life -t1/2 [Time frame: Up to 192 hours after the last dose]
  • The main PK parameters#Area under the plasma concentration versus time curve-AUC [Time frame: Up to 192 hours after the last dose]
  • The main PK parameters-CL/F (apparent clearance) [Time frame: Up to 192 hours after the last dose]
  • The main PK parameters-Vz/F (apparent volume of distribution) [Time frame: Up to 192 hours after the last dose]
Secondary outcome measures (1)
  • Incidence of adverse events [Time frame: Up to Day9]

Eligibility criteria

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.

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
Basic science

Study locations

China · 1 center
  • The First Affiliated Hospital of Bengbu Medical University — Bengbu

Identifiers

NCT: NCT07715149 · D2570-106

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗