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

Phase 1

Completed

• Conditions: Solid Tumor
• Interventions: Drug: Fuzuloparib

• Registration Number: NCT05440006
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-06-30
• Study Start: 2022-07-03
• Primary Completion: 2022-07-20
• Study Completion: 2022-07-20
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-06
• Last Update Posted: 2022-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fed+ Fasted	Fuzuloparib	The first cycle with high-fat meal, the second cycle under fasting.
Fasted + Fed	Fuzuloparib	The first cycle under fasting, the second cycle with high-fat meal.

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve from time 0 to last time of measurable concentration (AUC0-t)	day 1 to day 10
Maximum Plasma Concentration (Cmax)	day 1 to day 10
Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-∞ )	day 1 to day 10

Secondary Outcome Measures

Name	Time	Method
The incidence and severity of adverse events/serious adverse events	from ICF signing date to approximate day 23

Trial Locations

Locations (1)

Wannan Medical College Yijishan Hospital; 🇨🇳 Wuhu, Anhui, China