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

NCT05440006 | Completed Phase 1

• 1 other identifier: SHR3162-I-122
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• The incidence and severity of adverse events/serious adverse events

  from ICF signing date to approximate day 23

Study Arms (2)

Fed+ Fasted

EXPERIMENTAL

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

Drug: Fuzuloparib

Fasted + Fed

EXPERIMENTAL

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

Drug: Fuzuloparib

Interventions

Fuzuloparib DRUG

Fuzuloparib Capsules; 150mg; single dose per cycle.

Fasted + Fed; Fed+ Fasted

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female subjects over 18 years;
• 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);
• Participants should have no fertility plan from signing the informed consent until 6 months after the last dose, and take effective contraceptive measures.

You may not qualify if:

• Subjects with evidence of disease or major surgery;
• History of drug allergy;
• 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;
• 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;
• Those who have heavy smokers, alcoholics or drug abuse
• Lactating female subjects or fertile female subjects
• Those with clinically significant abnormality of physical examination, vital signs and laboratory test during the screening period.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Wannan Medical College Yijishan Hospital

Wuhu, Anhui, 241000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There will be 20 volunteers to receive the treatment, and each treatment will be followed by 72 hours of blood sampling for pharmacokinetic and safety.

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 30, 2022
• Study Start: July 3, 2022
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: September 8, 2022

Record last verified: 2022-09

Locations

CN (1)