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

Randomized, Open, Two Cycle, Two Sequence, Cross Reference Designed Study on the Effect of Food on the Pharmacokinetics of Fuzuloparib Capsules in Chinese Healthy Adult Subjects

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

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: Fuzuloparib

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Wuhu, Anhui, China, 241000
      • Wannan Medical College Yijishan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fed+ Fasted; The first cycle with high-fat meal, the second cycle under fasting.	Drug: Fuzuloparib; Fuzuloparib Capsules; 150mg; single dose per cycle.
Experimental: Fasted + Fed; The first cycle under fasting, the second cycle with high-fat meal.	Drug: Fuzuloparib; Fuzuloparib Capsules; 150mg; single dose per cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Plasma Concentration (Cmax)	day 1 to day 10
Area under the plasma concentration versus time curve from time 0 to last time of measurable concentration (AUC0-t)	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

Outcome Measure	Time Frame
The incidence and severity of adverse events/serious adverse events	from ICF signing date to approximate day 23

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2022
• Primary Completion (Actual): July 20, 2022
• Study Completion (Actual): July 20, 2022

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: SHR3162-I-122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No