Healthy Adult Male and Female VolunteersPhase 1NCT04341077
Study to Evaluate the Safety and Pharmacokinetics of Single-Dose Fluzoparib in Healthy Chinese Subjects
A Phase 1 study testing SHR3162 in people with Healthy Adult Male and Female Volunteers, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
Study to Evaluate the Safety and Pharmacokinetics of Single-Dose Fluzoparib in Healthy Chinese Subjects Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male and Female Volunteers
- What is being tested?
- SHR3162
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2020to 20 Oct 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase 1, Open-Label, One-Center Study to Evaluate the Safety and Pharmacokinetics of Single-Dose Fluzoparib in Healthy Chinese Subjects
Study to Evaluate the Safety and Pharmacokinetics of Single-Dose Fluzoparib in Healthy Chinese Subjects
Read the detailed description
This study will be a single-center, open-label, single dosing Fluzoparib study in healthy Chinese subjects to evaluate the pharmacokinetics and safety
- Conditions
- Healthy Adult Male and Female Volunteers
- Being tested
- SHR3162
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR3162Drug
A single oral dose of fluzoparib on Day 1
| Study group | Role | What they receive |
|---|---|---|
| SHR3162 | Experimental | A single dose of fluzoparib was administered orally Receives: Drug: SHR3162 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tmax
Time of the observed maximum plasma concentration of SHR3162
Measured: from Day1 to Day4
Cmax
Maximum observed plasma concentration of SHR3162
Measured: from Day1 to Day4
AUC0-t
Area under the plasma concentration-time curve from the time zero to the last quantifiable concentration of SHR3162
Measured: from Day1 to Day4
AUC0-inf
- Area under the plasma concentration-time curve from time zero extrapolated to infinity of SHR3162
Measured: from Day1 to Day4
T1/2
Terminal plasma elimination half-life of SHR3162
Measured: from Day1 to Day4
CL/F
Apparent clearance of SHR3162
Measured: from Day1 to Day4
Vz/F
Apparent volume of distribution of SHR3162
Measured: from Day1 to Day4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start10 Apr 2020 (estimated)
- Primary completion20 Apr 2020 (estimated)
- Study completion20 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult Male and Female VolunteersStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341077
- Sponsor's protocol ID
- SHR3162-I-114
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2020
- Last updated
- 10 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, One-Center Study to Evaluate the Safety and Pharmacokinetics of Single-Dose Fluzoparib in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT04341077
- Acronym / sponsor ID
- SHR3162-I-114
- Conditions
- Healthy Adult Male and Female Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2020 (estimated)
- Primary completion
- 20 Apr 2020 (estimated)
- Study completion
- 20 Oct 2020 (estimated)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to Evaluate the Safety and Pharmacokinetics of Single-Dose Fluzoparib in Healthy Chinese Subjects
Detailed description
This study will be a single-center, open-label, single dosing Fluzoparib study in healthy Chinese subjects to evaluate the pharmacokinetics and safety
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR3162 | Experimental | Drug: SHR3162A single dose of fluzoparib was administered orally |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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:
- 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;
Key exclusion criteria (15 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR3162A single oral dose of fluzoparib on Day 1 | Drug | SHR3162 |
Primary outcome
Tmax
Time frame: from Day1 to Day4
Time of the observed maximum plasma concentration of SHR3162
Cmax
Time frame: from Day1 to Day4
Maximum observed plasma concentration of SHR3162
AUC0-t
Time frame: from Day1 to Day4
Area under the plasma concentration-time curve from the time zero to the last quantifiable concentration of SHR3162
AUC0-inf
Time frame: from Day1 to Day4
• Area under the plasma concentration-time curve from time zero extrapolated to infinity of SHR3162
T1/2
Time frame: from Day1 to Day4
Terminal plasma elimination half-life of SHR3162
CL/F
Time frame: from Day1 to Day4
Apparent clearance of SHR3162
Vz/F
Time frame: from Day1 to Day4
Apparent volume of distribution of SHR3162
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR3162 in people with Healthy Adult Male and Female Volunteers, run by Jiangsu HengRui Medicine Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuya Wang, Ph.D (+86-13918749176, wangyuya@hrglobe.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tmax (time frame: from Day1 to Day4). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.