A Study of Food Effect on the Pharmacokinetics of Fuzuloparib Capsules in Chinese Healthy Adult Subjects

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Solid Tumor

Treatments: Drug: Fuzuloparib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05440006

SHR3162-I-122

Details and patient eligibility

About

The objective of the study is to assess the effect of food on the pharmacokinetics, and safety of Fuzuloparib Capsules in healthy subject.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male and female subjects over 18 years;
2. Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) of 19.0 to 26.0 kg /m2 (inclusive);
3. Participants should have no fertility plan from signing the informed consent until 6 months after the last dose, and take effective contraceptive measures.

Exclusion criteria

1. Subjects with evidence of disease or major surgery;
2. History of drug allergy;
3. Treatment with other investigational drug within 3 months, use of any prescription drugs, Chinese herbal supplements within 4 weeks, and/or need to use any over-the-counter (OTC), food supplements within 2 weeks before the first dose or during the trial;
4. Subjects refuse to stop drinking xanthine-rich beverages or foods at 48 hours before the first dose until the end of the study, and subjects refuse to stop any beverage or food containing grapefruit 7 days before the first dose;
5. Those who have heavy smokers, alcoholics or drug abuse
6. Lactating female subjects or fertile female subjects
7. Those with clinically significant abnormality of physical examination, vital signs and laboratory test during the screening period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Fed+ Fasted

Experimental group

Description:

The first cycle with high-fat meal, the second cycle under fasting.

Treatment:

Drug: Fuzuloparib

Fasted + Fed

Experimental group

Description:

The first cycle under fasting, the second cycle with high-fat meal.

Treatment:

Drug: Fuzuloparib