Food-Effect and Metabolism Study in Healthy Subjects

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03062982
• Other study ID #: FZPL-I-102-Food
• Status: Completed
• Phase: Phase 1
• First received: February 9, 2017
• Last updated: February 20, 2017
• Start date: December 21, 2016
• Est. completion date: January 4, 2017

Study information

• Verified date: February 2017
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 4, 2017
• Est. primary completion date: January 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• Fluzoparib
2 doses separated by 7 days.

Locations

Country	Name	City	State
China	the First Hosital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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