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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInventisBio Co., Ltd

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • D-2570

    Drug

    D-2570 tablet, administered orally as a single dose

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: D-2570 Group 1Experimental treatment 1 intervention
Group B: D-2570 Group 2Experimental treatment 1 intervention
Group C: D-2570 Group 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Up to 192 hours after the last dose
2

Maximum observed plasma concentration-Cmax

Maximum observed plasma concentration-Cmax

Time frame
Up to 192 hours after the last dose
3

The main PK parameters Half-life -t1/2

The main PK parameters Half-life -t1/2

Time frame
Up to 192 hours after the last dose
4

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

Time frame
Up to 192 hours after the last dose

Secondary outcomes

1

Incidence of adverse events

Incidence of adverse events

Time frame
Up to Day9

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.