A Phase 1 interventional study of Fluzoparib in Hepatic Impairment and Healthy Subjects, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Basic science
This study is designed to evaluate the safety and pharmacokinetics of Fluzoparib in subjects with impaired liver function in comparison with healthy subjects ,to develop dose recommendations for patients with hepatic impairment.
Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for subjects with impaired liver function:
Exclusion Criteria impaired liver function:
Inclusion Criteria for subjects with normal liver function:
Exclusion Criteria normal liver function:
Drug: Fluzoparib
Drug: Fluzoparib
Drug: Fluzoparib
A single oral dose of 50 mg Fluzoparib will be administered.
Pharmacokinetics parameters of Fluzoparib: Cmax
Time frame: through study completion, an averange of half year
Pharmacokinetics parameters of Fluzoparib: AUC0-t
Time frame: through study completion, an averange of half year
Pharmacokinetics parameters of Fluzoparib: AUC0-∞(if available)
Time frame: through study completion, an averange of half year
Other pharmacokinetics parameters of Fluzoparib: Tmax
Time frame: through study completion, an averange of half year
plasma protein binding rate of Fluzoparib
Time frame: through study completion, an averange of half year
The incidence and severity of adverse events/serious adverse events (based on NCI-CTCAE 5.0)
Time frame: through study completion, an averange of half year
Other pharmacokinetics parameters of Fluzoparib: T1/2 etc.
Time frame: through study completion, an averange of half year
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jiangsu HengRui Medicine Co., Ltd.