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Completed

NCT Number: NCT03062982

Food-Effect and Metabolism Study 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.

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Key information

Conditions

Solid Tumor

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

the First Hosital of Jilin University

Changchun, Jilin, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluzoparib

Drug

2 doses separated by 7 days.

Primary outcomes

  1. Pharmacokinetics - Cmax

    Time frame: pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h

    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.

  2. Pharmacokinetics-AUC

    Time frame: pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h

    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.

  3. Pharmacokinetics - Tmax (Hours)

    Time frame: pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h

    To estimate the the time to Maximum concentration and constructe the corresponding 90% confidence intervals.

  4. Collection of Feces and Urine and Measurement of 120mg Fluzoparib Metabolism in Healthy subjects by HPLC

    Time frame: 0-96h post dose if availabel

    This study was also designed to clarify the metabolism of Fluzoparib 120mg.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 24, 2017
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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