Study to Evaluate the Safety and Pharmacokinetics of Single-Dose Fluzoparib in Healthy Chinese Subjects

Healthy Adult Male and Female Volunteers Clinical Trial

Official title:

A Phase 1, Open-Label, One-Center Study to Evaluate the Safety and Pharmacokinetics of Single-Dose Fluzoparib in Healthy Chinese Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04341077
• Other study ID #: SHR3162-I-114
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 10, 2020
• Est. completion date: October 20, 2020

Study information

• Verified date: April 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Yuya Wang, Ph.D
• Phone: +86-13918749176
• Email: wangyuya[@]hrglobe.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study to Evaluate the Safety and Pharmacokinetics of Single-Dose Fluzoparib in Healthy Chinese Subjects

Description:

This study will be a single-center, open-label, single dosing Fluzoparib study in healthy Chinese subjects to evaluate the pharmacokinetics and safety

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: October 20, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy Chinese subjects, male and female, 18 to 45 years of age, inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests;

• Male body weight =50 kg, female body weight =45 kg, body mass index (BMI) between =18.0 and =29.0 kg/m2, inclusive;

• Female subjects agree not to be pregnant or lactating from beginning of the study screening to 90 days after trial completion:

• A negative blood and urine pregnancy test for females of childbearing potential at Screening and at Check-in, respectively;

• Females of reproductive potential are willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy; A highly effective method of contraception is defined as one that results in a low failure rate (ie, less than 1% per year), when used consistently and correctly. Females of non-childbearing potential will not be required to use contraception. Females of non-child bearing potential are defined as permanently sterile (eg, due to hysterectomy) or postmenopausal (defined as at least 12 months following cessation of menses without an alternative medical cause and serum FSH levels >25 IU/L).

• Males agree to refrain from donating sperm and fathering a child during the study and for at least 90 days after fluzoparib administration; male participants must agree to remain abstinent or must ensure a condom is used for all sexual activity (with a male or female partner) for this same duration.

• Able and willing to refrain from caffeine or caffeine-containing products, alcohol, fruit juices, and smoking/tobacco products from at least 48 hours prior to Check-In until the end of Safety Follow Up;

• Able and willing to refrain from eating and drinking poppy seed-containing products and grapefruit-related citrus fruits (eg, Seville oranges, pomelos) within 7 days prior to dosing until after collection of the final PK blood sample (Day 4);

• Able and willing to refrain from strenuous exercise (heavy lifting, weight training, calisthenics, aerobics) within 7 days prior to dosing until after collection of the final PK blood sample (Day 4);

• Willing and able to comply with all scheduled visits, study procedures, and provides written informed consent.

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neuropsychiatric disease, or any condition that may affect drug absorption, distribution, metabolism, and excretion;

• Had a severe infection, trauma or major surgery within 4 weeks of screening and at Check-In; plan to have a surgery during the trial;

• A past medical history of ECG abnormalities, documented cardiac arrhythmias, or cardiovascular disease; or QTcF interval >450 msec for males, >470 msec for females, or <300 msec;

• Subject's systolic blood pressure (SBP) is >140 or <90 mmHg, diastolic blood pressure (DBP) is >90 or <50 mmHg, resting heart rate <40 or >100 bpm, and respiratory rate <10 or >20 breaths/min at Screening or Check-in after resting in a semi-supine position for 5 minutes. Vitals can be repeated twice (a minimum of 1 to 2 minutes apart) based on the investigator's judgment;

• History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy (eg, hepatitis B or C);

• Subject has a history of type 1 hypersensitivity to any medication;

• Subject has evidence of substance abuse, a history of substance abuse, or is positive for drugs of abuse (eg, methamphetamines, opiates, methadone, cocaine, amphetamines, cannabinoids, tricyclic antidepressants, phencyclidine, barbiturates, benzodiazepines), or alcohol at Screening and Check-in (Day -1);

• History of symptomatic hypoglycemia;

• Subjects who smoke more than 5 cigarettes per day or will not refrain from smoking starting from at least 48 hours prior to screening and check-in on Day -1, and during the study;

• History of regular alcohol consumption in the past 3 months exceeding an average weekly intake of 14 standard drinks; 1 drink=5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor;

• Subject has used prescription medications within 14 days or, as per PI discretion, over-the-counter medications, dietary/nutritional supplements (except hormonal contraceptives, paracetamol under 2 grams/day, vitamin supplements) within 7 days or 5 half-lives prior to fluzoparib administration;

• Treatment with any investigational drug within 3 months (or 5 half-lives, whichever is longer) of dosing;

• Use of medications affecting liver metabolism within 1 month of screening;

• Blood donation or loss of more than 200 mL of blood within 1 month of screening; or blood donation or loss of more than 400 mL of blood within 3 months of screening; or received blood within 8 weeks of screening;

• Any other major illness/condition that, in the investigator's judgment, substantially increased the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response.

Related Conditions & MeSH terms

• Healthy Adult Male and Female Volunteers

Intervention

Drug:
• SHR3162
A single oral dose of fluzoparib on Day 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tmax	Time of the observed maximum plasma concentration of SHR3162	from Day1 to Day4
Primary	Cmax	Maximum observed plasma concentration of SHR3162	from Day1 to Day4
Primary	AUC0-t	Area under the plasma concentration-time curve from the time zero to the last quantifiable concentration of SHR3162	from Day1 to Day4
Primary	AUC0-inf	• Area under the plasma concentration-time curve from time zero extrapolated to infinity of SHR3162	from Day1 to Day4
Primary	T1/2	Terminal plasma elimination half-life of SHR3162	from Day1 to Day4
Primary	CL/F	Apparent clearance of SHR3162	from Day1 to Day4
Primary	Vz/F	Apparent volume of distribution of SHR3162	from Day1 to Day4