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

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05440006
• Other study ID #: SHR3162-I-122
• Status: Completed
• Phase: Phase 1
• Start date: July 3, 2022
• Est. completion date: July 20, 2022

Study information

• Verified date: September 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 20, 2022
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• Fuzuloparib
Fuzuloparib Capsules; 150mg; single dose per cycle.

Locations

Country	Name	City	State
China	Wannan Medical College Yijishan Hospital	Wuhu	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax)		day 1 to day 10
Primary	Area under the plasma concentration versus time curve from time 0 to last time of measurable concentration (AUC0-t)		day 1 to day 10
Primary	Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-8 )		day 1 to day 10
Secondary	The incidence and severity of adverse events/serious adverse events		from ICF signing date to approximate day 23