drugset / Trial / NCT05032235
Safety and Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Kidney Function
Non-randomizedParallel-groupOpen-labelBasic science
Summary
The primary objective is to evaluate pharmacokinetics of Fluzoparib and its main metabolite in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment. The secondary objective is to evaluate the safety of Fluzoparib in subjects with mild and moderate renal impairment and in healthy subjects.
Timeline
- Start
- 2021-11-09
- Primary completion
- 2023-12-04
- Completion
- 2023-12-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluzoparib | Small molecule | — | Oral |