Food-Effect and Metabolism Study in Healthy Subjects

Study Overview
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Brief Summary
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This study evaluates the food-effect of one-dose Fluzoparib in healthy subjects. The participants receive Fluzoparib 120mg in fed state in Period 1 followed by administration of Fluzoparib 120mg in fasted state in Period 2.

Official Title
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A Phase I, Open-label, 2-sequence, Cross-over, Pharmacokinetic (PK) Study to Evaluate the Effect of the Food and to Identify the Metabolism of Fluzoparib in Healthy Subjects

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: Fluzoparib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to give written informed consent. Must be willing to comply with the requirements of the study. Willing to use a medically acceptable method (as defined by the Investigator) of birth control in the 6 months. Male or female aged 18-50 years. Weight more than 45kg, BMI within 18 and 28 kg/m2. No clinically significant abnormalities in physical examination and lab tests. Exclusion Criteria: Pregnant or breast-feeding women. No history of alcohol or drug abuse within the past year. Participation in any clinical trial of an experimental drug or device in the previous 3 months. Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the subject unsuitable for the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Administration of 120mg in fed state in Dosing Period 1 followed by administration of 120mg in fasted state in Dosing Period 2 | Drug: Fluzoparib<br>* 2 doses separated by 7 days.<br>|
| Experimental: Group B<br>Administration of 120mg in fasted state in Dosing Period 1 followed by administration of 120mg in fed state in Dosing Period 2 | Drug: Fluzoparib<br>* 2 doses separated by 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics - Cmax | This study was designed to estimate the relative bioavailability of Fluzoparib 120 mg in the fed state relative to the fasted state.Peak Plasma Concentration (Cmax) and the the 90% confidence interval were calculated. | pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h | 
| Pharmacokinetics-AUC | This study was designed to estimate the relative bioavailability of Fluzoparib 120 mg in the fed state relative to the fasted state.Area under the plasma concentration versus time curve (AUC0-last，AUC0-infinity) and the 90% confidence intervals were calculated. | pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h | 
| Pharmacokinetics - Tmax (Hours) | To estimate the the time to Maximum concentration and constructe the corresponding 90% confidence intervals. | pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h | 
| Collection of Feces and Urine and Measurement of 120mg Fluzoparib Metabolism in Healthy subjects by HPLC | This study was also designed to clarify the metabolism of Fluzoparib 120mg. | 0-96h post dose if availabel |