Food-Effect and Metabolism Study in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: Fluzoparib

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China
      • the First Hosital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2016
• Primary Completion (Actual): January 4, 2017
• Study Completion (Actual): January 4, 2017

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 20, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: FZPL-I-102-Food

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No