Food-Effect and Metabolism Study in Healthy Subjects

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Solid Tumor

Treatments: Drug: Fluzoparib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03062982

FZPL-I-102-Food

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Group A

Experimental group

Description:

Administration of 120mg in fed state in Dosing Period 1 followed by administration of 120mg in fasted state in Dosing Period 2

Treatment:

Drug: Fluzoparib

Group B

Experimental group

Description:

Administration of 120mg in fasted state in Dosing Period 1 followed by administration of 120mg in fed state in Dosing Period 2

Treatment:

Drug: Fluzoparib