Healthy Adult SubjectsPhase 1NCT04395053
A Bioavailability Study of SHR1459 on Healthy Chinese Volunteers
A Phase 1 study testing SHR1459 in people with Healthy Adult Subjects, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The primary objective of the study is to evaluate the pharmacokinetics of healthy Chinese volunteers after oral administration of SHR1459 tablets in new and old formulations. The secondary objective of the study is to evaluate the safety after single dose of SHR1459 orally in healthy Chinese subjects. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- SHR1459
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2020to 1 Aug 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male subjects aged 18 or above (including 18 years old) at the date of signing the informed consent;
- Body weight ≥ 50kg, body mass index (BMI) within the range of 19 ~ 26kg /m2 (including 19 and 26 kg/m2) (BMI= weight (kg)/height 2 (m2));
- The subjects were able to communicate well with the researchers, understand and comply with the requirements of this study, understand and sign the informed consent;
- Consent to abstinence or take effective non-drug contraception measures during the study and for at least 3 months after the last drug administration.
Who cannot join
- Anyone who has suffered from any clinical serious disease such as the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities, or any other disease which can affect the study results. Researchers should focus on the following medical history: inflammatory gastroenteritis, gastroesophageal reflux, gastrointestinal or rectal bleeding, history of pancreatic injury or pancreatitis; larger history of surgery such as gastrectomy, gastrointestinal anastomosis or bowel resection;
- Have a history of allergies to drugs, food or other substances;
- Those who have undergone surgery within 4 weeks before the trial, or plan to undergo surgery during the study period;
- Those who have taken any drug (including Chinese herbal medicine, vitamins, calcium tablets and other food supplements) within 14 days before the study; Those who have taken any drug that inhibits or induces liver metabolic enzymes within 30 days before the study (such as inducer-barbiturate carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors-SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, vera pamil, fluoroquinolones, antihistamines);
- Those who participated in any clinical trial and took any clinical trial drugs within 3 months before the trial;
- Those who donated blood or suffered heavy blood loss (≥200 mL), received blood transfusions, or used blood products within 3 months before enrollment;
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- Volunteers who cannot adopt one or more non-drug contraception measures during the trial;
- Those who have special requirements on diet and cannot follow a unified diet;
- The subjects refused to stop any beverage or food containing methylxanthine, such as coffee, tea, cola, chocolate, etc. within 48 hours before the first dose until the end of the study; the subjects refused to discontinue any beverage or food containing grapefruit within 7 days before the first dose until the end of the study;
- Smokers or those who smoked more than 5 cigarettes per day in the 3 months before the trial or who could not stop using any tobacco products during the trial;
- Alcoholics or frequent drinkers within 6 months before the trial, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL of 40% spirits or 150 mL of wine), or those who receive the breath alcohol test and the results are positive, or who cannot stop using any alcoholic products during the trial;
- Those who receive the drug abuse or urine drug screening test and the results are positive.
- Those who regularly use sedatives, sleeping pills or other addictive drugs, have used soft drugs (such as cannabis) within 3 months before the trial or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the trial;
- Those with abnormal vital signs (systolic blood pressure < 90 mmHg or > 140 mmHg, diastolic blood pressure < 50 mmHg or > 90 mmHg; heart rate < 55 bpm or > 100 bpm) or the results of various clinical laboratory examination (including physical examination, electrocardiogram, chest radiograph, cardiac ultrasound, hematology, blood biochemistry, urinalysis, coagulation examination and virus serological detection) are abnormal and clinically significant based on the judgment of the clinical researchers;
- Creatinine clearance (CLCr) < 80 mL/min, creatinine clearance should be calculated using the standard Cockcroft-Gault formula;
- Volunteers are not able to complete the study for other reasons or other factors that are not suitable for participating in the study, as judged by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
About this study
Official title: Pharmacokinetic Evaluation Study of Healthy Chinese Volunteers After Oral Administration of SHR1459 Tablets in Old and New Formulation
The primary objective of the study is to evaluate the pharmacokinetics of healthy Chinese volunteers after oral administration of SHR1459 tablets in new and old formulations.
The secondary objective of the study is to evaluate the safety after single dose of SHR1459 orally in healthy Chinese subjects.
Read the detailed description
The PK parameters (AUC0-t, AUC0-inf, Cmax, Tmax, T1/2z, CL/F and Vz/F etc.) will be calculated to evaluate the pharmacokinetics of healthy Chinese volunteers after oral administration of SHR1459 tablets in new and old formulations.
During the study, the safety will be assessed by vital signs, physical examination, laboratory examination (hematology, blood biochemistry, urinalysis, coagulation examination), 12-lead electrocardiogram. The incidence and severity degree of adverse events and severe adverse events will be evaluated based on CTCAE 5.0.
- Conditions
- Healthy Adult Subjects
- Being tested
- SHR1459
- Keywords
- Bioavailability evaluation, Old formulation, New formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR1459Drug
Also called BTK inhibitor
TR group:
The first period，the subjects will be administrated with SHR-1459 in new formulation, then conduct blood collection within 48h; 7 days washout； The second period，the subjects will be administrated with SHR-1459 in old formulation, then conduct blood collection within 48h.
RT group:
The first period，the subjects will be administrated with SHR-1459 in old formulation, then conduct blood collection within 48h; 7 days washout； The second period，the subjects will be administrated with SHR-1459 in new formulation, then conduct blood collection within 48h.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group TR | Experimental | Intervention: Drug: SHR1459, new formulation; Intervention: Drug: SHR1459, old formulation. Receives: Drug: SHR1459 |
| Treatment group RT | Experimental | Intervention: Drug: SHR1459, old formulation; Intervention: Drug: SHR1459, new formulation. Receives: Drug: SHR1459 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameter: Cmax of SHR1459
Peak plasma concentration （Cmax）of SHR1459
Measured: through study completion, an average of 29 days
Pharmacokinetics parameter: AUC of SHR1459
Area under the plasma concentration versus time curve （AUC）of SHR1459
Measured: through study completion, an average of 29 days
Secondary outcomes (5)
Pharmacokinetics parameter: Tmax of SHR1459
Time of maximum observed concentration (Tmax) of SHR1459
Measured: through study completion, an average of 29 days
Pharmacokinetics parameter: T1/2z of SHR1459
Half time (T1/2z) of SHR1459
Measured: through study completion, an average of 29 days
Pharmacokinetics parameter: CL/F of SHR1459
Total body clearance for extravascular administration (CL/F) of SHR1459
Measured: through study completion, an average of 29 days
Pharmacokinetics parameter: Vz/F of SHR1459
Volume of distribution (Vz/F) of SHR1459
Measured: through study completion, an average of 29 days
The number of participants with treatment-related adverse events as assessed by CTCAE v5.0
An adverse event is any untoward medical occurrence in a patient or clinical study participant
Measured: through study completion, an average of 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start28 Jun 2020
- Primary completion11 Jul 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult 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
- Crossover
- Model description
- * Experimental: Treatment group TR Intervention: Drug: SHR1459, new formulation; Intervention: Drug: SHR1459, old formulation. * Experimental: Treatment group RT Intervention: Drug: SHR1459, old formulation; Intervention: Drug: SHR1459, new formulation.
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT04395053
- Sponsor's protocol ID
- SHR1459-I-104
- Status last verified
- Jul 2022
- First submitted
- 10 Apr 2020
- Last updated
- 7 Nov 2022
- 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 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Evaluation Study of Healthy Chinese Volunteers After Oral Administration of SHR1459 Tablets in Old and New Formulation
- ClinicalTrials.gov ID
- NCT04395053
- Acronym / sponsor ID
- SHR1459-I-104
- Conditions
- Healthy Adult Subjects
- Keywords
- Bioavailability evaluation, Old formulation, New formulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2020 (actual)
- Primary completion
- 11 Jul 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 20 May 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.
The primary objective of the study is to evaluate the pharmacokinetics of healthy Chinese volunteers after oral administration of SHR1459 tablets in new and old formulations.
The secondary objective of the study is to evaluate the safety after single dose of SHR1459 orally in healthy Chinese subjects.
Detailed description
The PK parameters (AUC0-t, AUC0-inf, Cmax, Tmax, T1/2z, CL/F and Vz/F etc.) will be calculated to evaluate the pharmacokinetics of healthy Chinese volunteers after oral administration of SHR1459 tablets in new and old formulations.
During the study, the safety will be assessed by vital signs, physical examination, laboratory examination (hematology, blood biochemistry, urinalysis, coagulation examination), 12-lead electrocardiogram. The incidence and severity degree of adverse events and severe adverse events will be evaluated based on CTCAE 5.0.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Experimental: Treatment group TR Intervention: Drug: SHR1459, new formulation; Intervention: Drug: SHR1459, old formulation. * Experimental: Treatment group RT Intervention: Drug: SHR1459, old formulation; Intervention: Drug: SHR1459, new formulation.
| Arm | Type | Receives |
|---|---|---|
| Treatment group TR | Experimental | Drug: SHR1459Intervention: Drug: SHR1459, new formulation; Intervention: Drug: SHR1459, old formulation. |
| Treatment group RT | Experimental | Drug: SHR1459Intervention: Drug: SHR1459, old formulation; Intervention: Drug: SHR1459, new formulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male subjects aged 18 or above (including 18 years old) at the date of signing the informed consent;
- Body weight ≥ 50kg, body mass index (BMI) within the range of 19 ~ 26kg /m2 (including 19 and 26 kg/m2) (BMI= weight (kg)/height 2 (m2));
- The subjects were able to communicate well with the researchers, understand and comply with the requirements of this study, understand and sign the informed consent;
- Consent to abstinence or take effective non-drug contraception measures during the study and for at least 3 months after the last drug administration.
Key exclusion criteria (16 listed)
- Anyone who has suffered from any clinical serious disease such as the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities, or any other disease which can affect the study results. Researchers should focus on the following medical history: inflammatory gastroenteritis, gastroesophageal reflux, gastrointestinal or rectal bleeding, history of pancreatic injury or pancreatitis; larger history of surgery such as gastrectomy, gastrointestinal anastomosis or bowel resection;
- Have a history of allergies to drugs, food or other substances;
- Those who have undergone surgery within 4 weeks before the trial, or plan to undergo surgery during the study period;
- Those who have taken any drug (including Chinese herbal medicine, vitamins, calcium tablets and other food supplements) within 14 days before the study; Those who have taken any drug that inhibits or induces liver metabolic enzymes within 30 days before the study (such as inducer-barbiturate carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors-SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, vera pamil, fluoroquinolones, antihistamines);
- Those who participated in any clinical trial and took any clinical trial drugs within 3 months before the trial;
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 |
|---|---|---|
| SHR1459Also: BTK inhibitorTR group: The first period，the subjects will be administrated with SHR-1459 in new formulation, then conduct blood collection within 48h; 7 days washout； The second period，the subjects will be administrated with SHR-1459 in old formulation, then conduct blood collection within 48h. RT group: The first period，the subjects will be administrated with SHR-1459 in old formulation, then conduct blood collection within 48h; 7 days washout； The second period，the subjects will be administrated with SHR-1459 in new formulation, then conduct blood collection within 48h. | Drug | Treatment group RT, Treatment group TR |
Primary outcome
Pharmacokinetics parameter: Cmax of SHR1459
Time frame: through study completion, an average of 29 days
Peak plasma concentration （Cmax）of SHR1459
Pharmacokinetics parameter: AUC of SHR1459
Time frame: through study completion, an average of 29 days
Area under the plasma concentration versus time curve （AUC）of SHR1459
5 secondary outcomes
Pharmacokinetics parameter: Tmax of SHR1459
Time frame: through study completion, an average of 29 days
Pharmacokinetics parameter: T1/2z of SHR1459
Time frame: through study completion, an average of 29 days
Pharmacokinetics parameter: CL/F of SHR1459
Time frame: through study completion, an average of 29 days
Pharmacokinetics parameter: Vz/F of SHR1459
Time frame: through study completion, an average of 29 days
The number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: through study completion, an average of 29 days
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 7 Nov 2022.
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Healthy Subjects
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 SHR1459 in people with Healthy Adult 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 4 inclusion and 16 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 7 Nov 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?
Pharmacokinetics parameter: Cmax of SHR1459 (time frame: through study completion, an average of 29 days). The study lists 2 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 7 Nov 2022.