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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04333134




Registration number
NCT04333134
Ethics application status
Date submitted
1/04/2020
Date registered
3/04/2020
Date last updated
22/07/2020

Titles & IDs
Public title
A Trial of SHR3162 in Healthy Caucasian Volunteers
Scientific title
A Phase 1, Open-Label, Two-Center Study to Evaluate the Safety and Pharmacokinetics of Single-Dose Fluzoparib in Healthy
Secondary ID [1] 0 0
SHR3162-I-113
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SHR3162

Experimental: Dose level 1 - Will enroll a single cohort of 12 healthy Caucasian subjects with an approximately one-to-one ratio of male to female subjectssubjects can be enrolled and dosed simultaneously.


Treatment: Drugs: SHR3162
Fluzoparib, also known as SHR3162, is an inhibitor of human PARP

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetic - Cmax - Maximum observed plasma concentration (Cmax) of SHR3162
Timepoint [1] 0 0
Pre-dose, 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 10, 24, 48, and 72 hr post-dose
Primary outcome [2] 0 0
Pharmacokinetic - AUC8 - Area under the concentration-time curve from time 0 to infinity of SHR3162
Timepoint [2] 0 0
Pre-dose, 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 10, 24, 48, and 72 hr post-dose
Primary outcome [3] 0 0
Pharmacokinetic - Tmax - Time to Cmax of SHR3162
Timepoint [3] 0 0
Pre-dose, 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 10, 24, 48, and 72 hr post-dose
Primary outcome [4] 0 0
Pharmacokinetic - CL/F - Apparent clearance of SHR3162
Timepoint [4] 0 0
Pre-dose, 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 10, 24, 48, and 72 hr post-dose
Primary outcome [5] 0 0
Pharmacokinetic - Vz/F - Apparent volume of distribution during terminal phase of SHR3162
Timepoint [5] 0 0
Pre-dose, 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 10, 24, 48, and 72 hr post-dose
Primary outcome [6] 0 0
Pharmacokinetic - t1/2 - Terminal elimination half-life of SHR3162
Timepoint [6] 0 0
Pre-dose, 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 10, 24, 48, and 72 hr post-dose
Secondary outcome [1] 0 0
Adverse events - Number of subjects with adverse events (AEs)
Timepoint [1] 0 0
Screening up to study completion, approximately 5 weeks
Secondary outcome [2] 0 0
Laboratory results - Number of subjects with laboratory tests findings of potential clinical importance
Timepoint [2] 0 0
Screening up to study completion, approximately 5 weeks
Secondary outcome [3] 0 0
Vital signs - Incidence of vital sign abnormalities
Timepoint [3] 0 0
Screening up to study completion, approximately 5 weeks
Secondary outcome [4] 0 0
Electrocardiogram - Number of subjects with clinically significant abnormal ECG QT Interval
Timepoint [4] 0 0
Screening up to study completion, approximately 5 weeks

Eligibility
Key inclusion criteria
1. Healthy Caucasian 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;

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

3. 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).

4. 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.

5. 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;

6. 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);

7. 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);

8. Willing and able to comply with all scheduled visits, study procedures, and provides
written informed consent.
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. 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;

2. 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;

3. 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;

4. 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;

5. 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);

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

7. 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);

8. History of symptomatic hypoglycemia;

9. 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;

10. 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;

11. 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;

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

13. Use of medications affecting liver metabolism within 1 month of screening;

14. 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;

15. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Atridia Pty Limited - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Atridia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety and PK characteristics of a single oral
dose of fluzoparib in healthy Caucasian and Chinese subjects
Trial website
https://clinicaltrials.gov/show/NCT04333134
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications