Pharmacokinetics of D-2570 in people with liver impairment and in healthy volunteers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, open-label, non-randomized, parallel-group Phase 1 study to characterize the pharmacokinetics and safety of D-2570 in participants with hepatic impairment and in those with normal hepatic function. Participants with liver impairment are enrolled first, followed by those with normal hepatic function. The study will monitor how the drug is absorbed, distributed, metabolized, and eliminated, along with safety measures in both groups. Enrollment will include adults aged 18 to 70, with weight and organ-function criteria to ensure safe dosing. The trial is sponsored by InventisBio Co., Ltd and conducted at The First Affiliated Hospital of Bengbu Medical University in Bengbu, Anhui.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Bengbu Medical University
  Bengbu, Anhui, China Recruiting

Study contacts

• Principal investigator: Huan Zhou — The First Affiliated Hospital of Bengbu Medical University
• Study coordinator: Huan Zhou
• Email: zhouhuanbest@vip.163.com
• Phone: +86 0552-3085747

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.