Healthy Male SubjectsPhase 1NCT04850638
Drug Interaction Between SHR4640 Tablets and Furosemide Tablets in Healthy Volunteers (Single Center, Single Arm, Open, Self-control)
A Phase 1 study testing SHR4640 tablets and furosemide tablets in people with Healthy Male Subjects, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study was to evaluate the effect of SHR4640 tablets on the pharmacokinetics of furosemide tablets in healthy male volunteers, using a single-center, single-arm, open, self-control design. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Subjects
- What is being tested?
- SHR4640 tablets and furosemide tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2021to 14 Sep 2021
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily sign the informed consent form before the start of the activities related to this trial, and be able to understand the procedures and methods of this trial, and be willing to strictly abide by the clinical trial plan to complete this trial;
- Adult males aged between 18 and 45 (including both ends, whichever is the time of signing the informed consent form);
- Body weight ≥ 50kg and body mass index (BMI): 19~26kg/m2 (including both ends).
Who cannot join
- Have a fertility plan or refuse to use medically approved contraceptives within 1 month from the screening period to the last medication;
- Smokers (those who smoke more than 5 cigarettes per day on average);
- During the first month of screening, the average daily alcohol intake was more than 25g (for example, 750mL beer, 250mL wine, or 50mL liquor) or those who were positive for alcohol in blood test or alcohol breath test during screening;
- Those who have eaten grapefruit or its fruit juice products, any caffeine (such as coffee, tea, chocolate, cola or other caffeinated carbonated drinks, etc.), alcoholic food or beverages within 2 days before administration;
- Drug abusers or those who were positive in urine drug test during screening;
- The researchers judged that the subjects had medical conditions that affected the absorption, distribution, metabolism and excretion of drugs or reduced compliance
Show all 20Show fewer
- Any clinical history of serious illness or any disease or condition that the researchers believe may affect the results of the trial, including, but not limited to, a history of circulatory, endocrine, nervous system, digestive, urinary or blood, immune, mental and metabolic diseases;
- Allergic constitution, or allergic to any ingredient in SHR4640 and furosemide tablets, or allergic to sulfonamides or thiazide diuretics, or allergic to any food ingredient, or having special dietary requirements, unable to follow a uniform diet;
- Previous history of urinary diseases (such as benign prostatic hyperplasia, urinary tract stenosis) or other diseases that lead to dysuria;
- Screen those who have undergone any operation within the first 3 months, or who have not recovered after the operation, or who may have a plan for operation or hospitalization during the trial;
- Those who donated blood (or lost blood) and donated blood (or lost blood) ≥ 400 mL within 3 months before screening, or received blood transfusion;
- During screening, physical examination, vital signs, laboratory examination (whole blood cell analysis, blood biochemical analysis, blood electrolyte examination, urine analysis, fasting blood lipids, thyroid function), 12-lead ECG, X-chest X-ray and abdominal B-ultrasound were abnormal and had clinical significance.
- When screening, systolic blood pressure was less than 90mmHg or greater than 140mmHg, and / or diastolic blood pressure was less than 60mmHg or greater than 90mmHg;
- Urinary system ultrasound suggested or suspected urinary system crystals or stones during screening;
- Those whose serum uric acid was higher than 420 μ mol / L or had a previous history of hyperuricemia and / or gout;
- The level of serum potassium was lower than that of 4.0mmol/L during screening.
- According to the serum creatinine within 2 weeks before administration, the glomerular filtration rate ((estimated glomerular filtration rate, eGFR) calculated by the simplified kidney disease diet adjustment (modification of diet in renal disease, MDRD) formula (Annex 1) is less than 90 mL/min/1.73 m ².
- Those who were positive for hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody, or syphilis antibody within one month before the screening;
- Screening people who have participated in any drug or medical device clinical trial within the previous 3 months (subject to signing informed consent);
- Used any prescription drugs, over-the-counter drugs, Chinese herbal medicines or dietary supplements within 2 weeks before screening.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to evaluate the effect of SHR4640 tablets on the pharmacokinetics of furosemide tablets in healthy male volunteers, using a single-center, single-arm, open, self-control design.
- Conditions
- Healthy Male Subjects
- Being tested
- SHR4640 tablets and furosemide tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR4640 tablets and furosemide tabletsDrug
SHR4640 tablets and furosemide tablets
| Study group | Role | What they receive |
|---|---|---|
| SHR4640 tablets | Experimental | Not described Receives: Drug: SHR4640 tablets and furosemide tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak plasma concentration
Measured: Day1 to Day10
AUC0-t
Area under the curve from the time of dosing. Dosing time to the last measurable (positive) concentration.
Measured: Day1 to Day10
AUC0-inf (if available)
Area under the curve from time 0 to infinity
Measured: Day1 to Day10
Ae
Cumulative Amount of excretion
Measured: Day1 to Day10
CLr
Renal Clearance
Measured: Day1 to Day10
Secondary outcomes (4)
t1/2
Half time
Measured: Day1 to Day10
Tmax
Time of maximum observed concentration.
Measured: Day1 to Day10
CL/F
apparent clearance
Measured: Day1 to Day10
Vz/F
apparent volume of distribution
Measured: Day1 to Day10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start28 Jun 2021
- Primary completion5 Sep 2021
- Study completion14 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male SubjectsStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
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
- NCT04850638
- Sponsor's protocol ID
- SHR4640-108
- Status last verified
- Jul 2022
- First submitted
- 19 Apr 2021
- Last updated
- 11 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Interaction Between SHR4640 Tablets and Furosemide Tablets in Healthy Volunteers (Single Center, Single Arm, Open, Self-control)
- ClinicalTrials.gov ID
- NCT04850638
- Acronym / sponsor ID
- SHR4640-108
- Conditions
- Healthy Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 5 Sep 2021 (actual)
- Study completion
- 14 Sep 2021 (actual)
- First posted
- 20 Apr 2021 (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.
The purpose of this study was to evaluate the effect of SHR4640 tablets on the pharmacokinetics of furosemide tablets in healthy male volunteers, using a single-center, single-arm, open, self-control design.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR4640 tablets | Experimental | Drug: SHR4640 tablets and furosemide tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Voluntarily sign the informed consent form before the start of the activities related to this trial, and be able to understand the procedures and methods of this trial, and be willing to strictly abide by the clinical trial plan to complete this trial;
- Adult males aged between 18 and 45 (including both ends, whichever is the time of signing the informed consent form);
- Body weight ≥ 50kg and body mass index (BMI): 19~26kg/m2 (including both ends).
Key exclusion criteria (20 listed)
- Have a fertility plan or refuse to use medically approved contraceptives within 1 month from the screening period to the last medication;
- Smokers (those who smoke more than 5 cigarettes per day on average);
- During the first month of screening, the average daily alcohol intake was more than 25g (for example, 750mL beer, 250mL wine, or 50mL liquor) or those who were positive for alcohol in blood test or alcohol breath test during screening;
- Those who have eaten grapefruit or its fruit juice products, any caffeine (such as coffee, tea, chocolate, cola or other caffeinated carbonated drinks, etc.), alcoholic food or beverages within 2 days before administration;
- Drug abusers or those who were positive in urine drug test during screening;
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 |
|---|---|---|
| SHR4640 tablets and furosemide tabletsSHR4640 tablets and furosemide tablets | Drug | SHR4640 tablets |
Primary outcome
Cmax
Time frame: Day1 to Day10
Peak plasma concentration
AUC0-t
Time frame: Day1 to Day10
Area under the curve from the time of dosing. Dosing time to the last measurable (positive) concentration.
AUC0-inf (if available)
Time frame: Day1 to Day10
Area under the curve from time 0 to infinity
Ae
Time frame: Day1 to Day10
Cumulative Amount of excretion
CLr
Time frame: Day1 to Day10
Renal Clearance
4 secondary outcomes
t1/2
Time frame: Day1 to Day10
Tmax
Time frame: Day1 to Day10
CL/F
Time frame: Day1 to Day10
Vz/F
Time frame: Day1 to Day10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR4640 tablets and furosemide tablets in people with Healthy Male Subjects, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
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 3 inclusion and 20 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: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Day1 to Day10). The study lists 5 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 11 Jul 2022.