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

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05440006
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
2.4
Anticipated Duration (Months)
8.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jul 3, 2022
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Sep 15, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Maximum Plasma Concentration (Cmax) [day 1 to day 10]

  2. Area under the plasma concentration versus time curve from time 0 to last time of measurable concentration (AUC0-t) [day 1 to day 10]

  3. Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-∞ ) [day 1 to day 10]

Secondary Outcome Measures

  1. The incidence and severity of adverse events/serious adverse events [from ICF signing date to approximate day 23]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wannan Medical College Yijishan Hospital Wuhu Anhui China 241000

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05440006
Other Study ID Numbers:
  • SHR3162-I-122
First Posted:
Jun 30, 2022
Last Update Posted:
Jul 29, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 29, 2022