Safety and Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Liver Function
- Registration Number
- NCT04694365
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal Hepatic Function Fluzoparib - Moderate Hepatic Impairment Fluzoparib - Mild Hepatic Impairment Fluzoparib -
- Primary Outcome Measures
Name Time Method Pharmacokinetics parameters of Fluzoparib: AUC0-t through study completion, an averange of half year Pharmacokinetics parameters of Fluzoparib: AUC0-∞(if available) through study completion, an averange of half year Pharmacokinetics parameters of Fluzoparib: Cmax through study completion, an averange of half year
- Secondary Outcome Measures
Name Time Method plasma protein binding rate of Fluzoparib through study completion, an averange of half year Other pharmacokinetics parameters of Fluzoparib: Tmax through study completion, an averange of half year The incidence and severity of adverse events/serious adverse events (based on NCI-CTCAE 5.0) through study completion, an averange of half year Other pharmacokinetics parameters of Fluzoparib: T1/2 etc. through study completion, an averange of half year
Trial Locations
- Locations (1)
Henan Infectious Diseases Hospital
🇨🇳Zhengzhou, Henan, China