Healthy Male SubjectsPhase 1SHR-3680NCT04903158
Relative Bioavailability Study of SHR3680
A Phase 1 study testing test SHR3680 tablets and reference SHR3680 tablets in people with Healthy Male Subjects, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, single-dose, randomized, open-label, parallel sstudy to evaluate the relative bioavailability of new and old formulations of SHR3680 tablets in healthy male subjects under fasting conditions. 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?
- test SHR3680 tablets and reference SHR3680 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2021to May 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
- Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
- Ability to complete the study as required by the protocol;
- Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent, and less than 10-year between minimum age and maximum age of the whole subjects;
- Body weight ≥ 50 kg, and body mass index (BMI) within the range of 19 ~ 26 kg /m2 (including 19 and 26);
- Agreement to avoid sperm donation for 3 months days after the dose of SHR3680;
- Glomerular filtration rate (GFR) ≥ 90mL / min / 1.73m2 (see Appendix 1 of the clinical trial protocol for the calculation formula of GFR);
Who cannot join
- Any history of epilepsy, including childhood febrile seizures, loss of consciousness, transient ischemic attacks or any conditions that may lead to seizures, such as cerebrovascular disease, brain injury, stroke or brain cancer, etc;
- Any subject who had any clinically significant acute diseases within one month before screening, including fever or fever as his clinical symptoms, virus, bacteria (including upper respiratory tract infection) or fungi (non-skin) infections;
- Loss of more than 400 mL blood during the 3 months before the trial (eg, as a blood donor);
- Allergic constitution;
- History of drug use, or drug abuse screening positive;
- Alcoholic or often drinkers;
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- A smoker with 5 cigarettes per day for more than 90 days;
- Positive serology for hepatitis B surface antigen (HBsAg) and HCV (healthy participants), anti-treponema pallidum virus (TP), or antihuman immunodeficiency virus (HIV) Type 1 and Type 2 (all subjects);
- Use of any drugs or substances known to be inhibitors or inducers of CYP enzymes within 90 days from the first dose or 5 half-lives, if known, of the drugs or substances, whichever is greater, prior to SHR3680 administration and during the study.
- A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
- Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.
- From 48 hours before taking the study drug to the end of the study, any subject refused to stop using any drinks containing methylxanthine (such as coffee, tea, cola, chocolate, etc.), alcoholic drinks and any fruit juice; they took drinks or foods containing grapefruit 7 days before the first administration of the study drug;
- Those who received vaccination within 3 months before screening.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Guangzhou Medical University
Guanzhou, Guangdong
About this study
Official title: A Single-Center, Single-Dose, Randomized, Open-Label, Parallel Study of Relative Bioavailability With Oral Administration of New and Old Formulations of SHR3680 Tablets in Healthy Male Subjects Under Fasting Conditions
This is a single-center, single-dose, randomized, open-label, parallel sstudy to evaluate the relative bioavailability of new and old formulations of SHR3680 tablets in healthy male subjects under fasting conditions.
- Conditions
- Healthy Male Subjects
- Being tested
- test SHR3680 tablets, reference SHR3680 tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test SHR3680 tabletsDrug
Subjects receiving a single oral dose of SHR3680 tablets with 240mg (80mg*3)
reference SHR3680 tabletsDrug
subjects receiving a single oral dose of SHR3680 tablets with 240mg (100mg*2+20mg*2).
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Test formulation of SHR3680 Receives: Drug: test SHR3680 tablets |
| Reference group | Other | Reference formulation of SHR3680. Receives: Drug: reference SHR3680 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fr
Fr=AUC (test formulation)/AUC (reference formulation)
Measured: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
Cmax
Measured: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
AUC0-t
Measured: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
AUC0-∞
Measured: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
Secondary outcomes (5)
Tmax
Measured: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
T1/2
Measured: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
Vd
Measured: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
CL/F
Measured: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
The incidence and severity of adverse events/serious adverse events (based on NCI-CTCAE 5.0)
Measured: From the screening to the scheduled last visit day (Day 49±1 after dosing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start6 Jan 2021
- Primary completion15 Mar 2021
- Study completionMay 2021 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT04903158
- Sponsor's protocol ID
- SHR3680-BA
- Acronym
- SHR-3680
- Status last verified
- May 2021
- First submitted
- 6 May 2021
- Last updated
- 26 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Single-Dose, Randomized, Open-Label, Parallel Study of Relative Bioavailability With Oral Administration of New and Old Formulations of SHR3680 Tablets in Healthy Male Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT04903158
- Acronym / sponsor ID
- SHR-3680 / SHR3680-BA
- Conditions
- Healthy Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- May 2021 (estimated)
- First posted
- 26 May 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.
This is a single-center, single-dose, randomized, open-label, parallel sstudy to evaluate the relative bioavailability of new and old formulations of SHR3680 tablets in healthy male subjects under fasting conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: test SHR3680 tabletsTest formulation of SHR3680 |
| Reference group | Other | Drug: reference SHR3680 tabletsReference formulation of SHR3680. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
- Ability to complete the study as required by the protocol;
- Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent, and less than 10-year between minimum age and maximum age of the whole subjects;
- Body weight ≥ 50 kg, and body mass index (BMI) within the range of 19 ~ 26 kg /m2 (including 19 and 26);
- Agreement to avoid sperm donation for 3 months days after the dose of SHR3680;
Key exclusion criteria (13 listed)
- Any history of epilepsy, including childhood febrile seizures, loss of consciousness, transient ischemic attacks or any conditions that may lead to seizures, such as cerebrovascular disease, brain injury, stroke or brain cancer, etc;
- Any subject who had any clinically significant acute diseases within one month before screening, including fever or fever as his clinical symptoms, virus, bacteria (including upper respiratory tract infection) or fungi (non-skin) infections;
- Loss of more than 400 mL blood during the 3 months before the trial (eg, as a blood donor);
- Allergic constitution;
- History of drug use, or drug abuse screening positive;
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 |
|---|---|---|
| test SHR3680 tabletsSubjects receiving a single oral dose of SHR3680 tablets with 240mg (80mg*3) | Drug | Test group |
| reference SHR3680 tabletssubjects receiving a single oral dose of SHR3680 tablets with 240mg (100mg*2+20mg*2). | Drug | Reference group |
Primary outcome
Fr
Time frame: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
Fr=AUC (test formulation)/AUC (reference formulation)
Cmax
Time frame: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
AUC0-t
Time frame: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
AUC0-∞
Time frame: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
5 secondary outcomes
Tmax
Time frame: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
T1/2
Time frame: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
Vd
Time frame: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
CL/F
Time frame: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing
The incidence and severity of adverse events/serious adverse events (based on NCI-CTCAE 5.0)
Time frame: From the screening to the scheduled last visit day (Day 49±1 after dosing)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
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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 test SHR3680 tablets and reference SHR3680 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 6 inclusion and 13 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 26 May 2021. 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?
Results are not available in the source record.
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?
Fr (time frame: predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing). The study lists 4 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 26 May 2021.