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
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
Treatments tested in this trial
- D-2570
Treatment groups
24 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov