Type II DiabetesPhase 1NCT04540016
Mass Balance and Biotransformation of [14C]HSK7653 in Human
A Phase 1 study testing [14C]HSK7653 in people with Type II Diabetes, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 1 site in China.
Trial summary
A single-center, single-dose, non-randomized, open-label 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
- Type II Diabetes
- What is being tested?
- [14C]HSK7653
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2020to 21 Jan 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
- Healthy Chinese males, aged 18-45 years old (inclusive);
- Body weight ≥ 50.0 kg and body mass index (BMI) between 19.0-26.0 kg/m2 (inclusive);
- Subjects who voluntarily sign the informed consent form (ICF), able to communicate with the investigator and to complete all trial procedures as per the protocol.-
Who cannot join
- Those who meet any of the following should not be enrolled:
- Clinical examination:
- Clinically significant abnormal results for comprehensive physical examination, vital signs, routine laboratory tests [blood routine, blood biochemistry, coagulation routine, urine routine, stool routine + occult blood, thyroid function, oral glucose tolerance test (fasting blood glucose, 2-hour blood glucose), glycated hemoglobin], visual acuity and ophthalmic examination (slit lamp, introcular pressure, and fundoscopy), 12-lead electrocardiogram (ECG), chest X-ray (anteriorposterior), and abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, and kidney);
- Positive for hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody, or Treponema pallidum antibodies;
- Medication history:
- Use of any Western medicine or Chinese patent medicine (including prescription drug, over-the-counter drug, health care product, or live attenuated influenza vaccine) within 14 days prior to screening;
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- Participation in any clinical trial and interference with other investigational drug or medical device within 3 month prior to screening;
- Medical history and surgical history:
- History of serious clinical diseases or diseases/conditions that the investigator believes may affect the study results, including but not limited to the history of diseases in the motor system, nervous system, endocrine system, circulatory system, respiratory system, digestive system, urinary system, and reproductive system;
- Past history of organic heart disease, heart failure, myocardial infarction, angina, unexplained arrhythmia, torsades de pointes, ventricular tachycardia, long QT syndrome or symptoms and familial history of long QT syndrome (indicated by genetic evidence or sudden death of a close relative at a young age due to cardiac causes);
- Have undergone major surgery within 6 months prior to screening or with incomplete healing of the surgical incision; major surgery includes, but is not limited to, any surgery with significant risk of bleeding, prolonged general anesthesia, or incisional biopsy or obvious traumatic injury (excluding cured appendicitis surgery or rectal prolapse surgery);
- Severe allergic constitution, including known allergy to DPP-4 inhibitors or any excipient of this investigational product (mannitol, microcrystalline cellulose), two or more drugs and food components, or with special dietary requirements and thus unable to follow a standardized diet;
- With commitment acute/chronic bronchospasm (asthma, chronic obstructive pulmonary disease), pulmonary fibrosis, pulmonary tuberculosis, untreated pneumonitis, or other diseases that affect respiratory function;
- History of severe hypoglycemic seizure (such as hypoglycemia-induced somnolence, disturbance of consciousness, disorganized speech, or even coma), or history of severe hypoglycemia unawareness;
- Volunteers judged by the investigator to be unsuitable for participating in this trial for any reason.-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial on Absorption, Metabolism, and Excretion of [14C]HSK7653 in Healthy Adult Male Chinese Subjects - Mass Balance and Biotransformation of [14C]HSK7653 in Human
A single-center, single-dose, non-randomized, open-label design.
Read the detailed description
Six healthy adult male subjects will be enrolled and the trial will be carried out in two steps:
Step 1: Two eligible male subjects are enrolled and admitted to the clinical study site after passing verification against inclusion and exclusion criteria on Day -2. After being admitted, the subjects are trained regarding drug administration and urine and stool collection procedures to ensure that they are able to perform relevant operations according to the protocol and SOP requirements. Subjects are deprived of food for at least 10 h and of water for 1 h before drug administration. After oral administration of investigational product in the morning of Day 1 under fasted condition, each subject will be deprived of food for 4 h and of water for 1 h.
Dense sampling is scheduled for all urine and stool samples excreted at specified time intervals within 0-336 h post-dose as well as blood samples at specified time points within 0-336 h post-dose. Sample collection and corresponding safety monitoring will be completed in the morning of Day 15 (the specific time will be decided by the investigator and sponsor based on the phased test results, safety results, and the actual situation) before the subjects leave the phase I clinical trial ward. Subjects will return to the ward on Days 19, 26, 33, and 40 to complete biological sample collection and vital sign monitoring according to protocol requirements. Subjects will return to the ward on Day 47 to complete the last biological sample collection (scheduled to be 1176 h after administration) and various withdrawal examinations according to protocol requirements.
The trial employs phased testing to determine whether the dense sampling and sparse sampling time points should be adjusted and whether collection of blood, urine, and stool samples can be prematurely stopped or should be continued for an extended period based on the test results. If biological sampling duration exceeds 1176 h in this study, then sampling will continue at an interval of 7 days until the protocol-specified evaluation criteria for sampling termination is satisfied. Safety monitoring will continue until the date of sampling completion. The test results in step 1 will be used to determine whether the trial procedure needs to be adjusted.
Step 2: Four eligible male subjects will be enrolled and blood, urine, and stool samples will be collected at specified time points/intervals. The procedures are the same as step 1.
Criteria for sampling termination:
Excretion: The radioactivity of biological samples (urine + stool) collected over two consecutive time intervals from the subject is less than 1% of the dose.
Radioactive blood samples: Plasma radioactivity concentrations at two consecutive time points are < 3 times background plasma concentration.
The target total radioactivity of biological samples (urine + stool) collected from each subject is not lower than 80% of the dose. The investigator should finally determine whether to stop sampling of a subject based on the comprehensive evaluation of radioactive test results, safety results and the actual situation.
The entire trial is based on the complete test samples and data collected from 6 subjects. All subjects must complete the trial procedures according to the protocol requirements during admission in the clinical study site and they are not allowed to leave the clinical study site without permission by the investigator.
Subject may withdraw from the study upon confirmation by the investigator provided that no clinically significant abnormality is observed in clinical observation after completion of the trial. Should any clinically significant abnormality be found, the subject will continue to stay at the study site for observation or leave the study site after comprehensive assessment by the investigator and periodically (usually 7 days from the last test) return to the hospital for retests and followed up until recovery to normal, the abnormality is not clinically significant, or a level deemed acceptable by the investigator.
- Conditions
- Type II Diabetes
- Being tested
- [14C]HSK7653
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]HSK7653Drug
25 mg of [14C]HSK7653 (radioactivity of 80 µCi) capsules are taken under fasted condition.
| Study group | Role | What they receive |
|---|---|---|
| Arm Ⅰ | Other | 25 mg of 80 µCi [14C]HSK7653. Receives: Drug: [14C]HSK7653 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of cumulative drug excretion of [14C]HSK7653 on biological specimens(urine and faeces) accounting for total radiation drug dose
Though collecting different periods of biological specimens(urine and faeces) , detecting their respective drug excretion of [14C]HSK7653，calculating the total cumulative excretion amount and relevant proportion of each kind of specimen(urine or faeces).
Measured: From the start of administration to 50 day after administration
Peak concentration (Cmax)
Pharmacokinetic Measures
Measured: From the start of administration to 50 day after administration
Area under the concentration-time curve (AUC0-t, AUC0-∞)
Pharmacokinetic Measures
Measured: From the start of administration to 50 day after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start15 Nov 2020
- Primary completion14 Jan 2021
- Study completion21 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-center, single-dose, non-randomized, open-label design.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- First Affiliated Hospital of Suzhou Medical College
- Responsible party
- Sponsor
- Investigators
- Liyan Miao, PhD, Principal investigator, Medical Ethics Committee of the First Affiliated Hospital of soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540016
- Sponsor's protocol ID
- HSK7653-103
- Status last verified
- Dec 2022
- First submitted
- 25 Aug 2020
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bian YC, Meng J, Hu T, Ma S, Huang CR, Zhang FY, Wu QH, Zhang H, Chen XY, Miao LY. Biotransformation and disposition characteristics of HSK7653, a novel long-acting dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes. Diabetes Obes Metab. 2024 Jul;26(7):2860-2868. doi: 10.1111/dom.15605. Epub 2024 Apr 22.
PubMed 38646838
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial on Absorption, Metabolism, and Excretion of [14C]HSK7653 in Healthy Adult Male Chinese Subjects - Mass Balance and Biotransformation of [14C]HSK7653 in Human
- ClinicalTrials.gov ID
- NCT04540016
- Acronym / sponsor ID
- HSK7653-103
- Conditions
- Type II Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- First Affiliated Hospital of Suzhou Medical College
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 7 Sep 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.
A single-center, single-dose, non-randomized, open-label design.
Detailed description
Six healthy adult male subjects will be enrolled and the trial will be carried out in two steps:
Step 1: Two eligible male subjects are enrolled and admitted to the clinical study site after passing verification against inclusion and exclusion criteria on Day -2. After being admitted, the subjects are trained regarding drug administration and urine and stool collection procedures to ensure that they are able to perform relevant operations according to the protocol and SOP requirements. Subjects are deprived of food for at least 10 h and of water for 1 h before drug administration. After oral administration of investigational product in the morning of Day 1 under fasted condition, each subject will be deprived of food for 4 h and of water for 1 h.
Dense sampling is scheduled for all urine and stool samples excreted at specified time intervals within 0-336 h post-dose as well as blood samples at specified time points within 0-336 h post-dose. Sample collection and corresponding safety monitoring will be completed in the morning of Day 15 (the specific time will be decided by the investigator and sponsor based on the phased test results, safety results, and the actual situation) before the subjects leave the phase I clinical trial ward. Subjects will return to the ward on Days 19, 26, 33, and 40 to complete biological sample collection and vital sign monitoring according to protocol requirements. Subjects will return to the ward on Day 47 to complete the last biological sample collection (scheduled to be 1176 h after administration) and various withdrawal examinations according to protocol requirements.
The trial employs phased testing to determine whether the dense sampling and sparse sampling time points should be adjusted and whether collection of blood, urine, and stool samples can be prematurely stopped or should be continued for an extended period based on the test results. If biological sampling duration exceeds 1176 h in this study, then sampling will continue at an interval of 7 days until the protocol-specified evaluation criteria for sampling termination is satisfied. Safety monitoring will continue until the date of sampling completion. The test results in step 1 will be used to determine whether the trial procedure needs to be adjusted.
Step 2: Four eligible male subjects will be enrolled and blood, urine, and stool samples will be collected at specified time points/intervals. The procedures are the same as step 1.
Criteria for sampling termination:
Excretion: The radioactivity of biological samples (urine + stool) collected over two consecutive time intervals from the subject is less than 1% of the dose.
Radioactive blood samples: Plasma radioactivity concentrations at two consecutive time points are < 3 times background plasma concentration.
The target total radioactivity of biological samples (urine + stool) collected from each subject is not lower than 80% of the dose. The investigator should finally determine whether to stop sampling of a subject based on the comprehensive evaluation of radioactive test results, safety results and the actual situation.
The entire trial is based on the complete test samples and data collected from 6 subjects. All subjects must complete the trial procedures according to the protocol requirements during admission in the clinical study site and they are not allowed to leave the clinical study site without permission by the investigator.
Subject may withdraw from the study upon confirmation by the investigator provided that no clinically significant abnormality is observed in clinical observation after completion of the trial. Should any clinically significant abnormality be found, the subject will continue to stay at the study site for observation or leave the study site after comprehensive assessment by the investigator and periodically (usually 7 days from the last test) return to the hospital for retests and followed up until recovery to normal, the abnormality is not clinically significant, or a level deemed acceptable by the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-center, single-dose, non-randomized, open-label design.
| Arm | Type | Receives |
|---|---|---|
| Arm Ⅰ | Other | Drug: [14C]HSK765325 mg of 80 µCi [14C]HSK7653. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Chinese males, aged 18-45 years old (inclusive);
- Body weight ≥ 50.0 kg and body mass index (BMI) between 19.0-26.0 kg/m2 (inclusive);
- Subjects who voluntarily sign the informed consent form (ICF), able to communicate with the investigator and to complete all trial procedures as per the protocol.-
Key exclusion criteria (15 listed)
- Clinically significant abnormal results for comprehensive physical examination, vital signs, routine laboratory tests [blood routine, blood biochemistry, coagulation routine, urine routine, stool routine + occult blood, thyroid function, oral glucose tolerance test (fasting blood glucose, 2-hour blood glucose), glycated hemoglobin], visual acuity and ophthalmic examination (slit lamp, introcular pressure, and fundoscopy), 12-lead electrocardiogram (ECG), chest X-ray (anteriorposterior), and abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, and kidney);
- Positive for hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody, or Treponema pallidum antibodies;
- Use of any Western medicine or Chinese patent medicine (including prescription drug, over-the-counter drug, health care product, or live attenuated influenza vaccine) within 14 days prior to screening;
- Participation in any clinical trial and interference with other investigational drug or medical device within 3 month prior to screening;
- History of serious clinical diseases or diseases/conditions that the investigator believes may affect the study results, including but not limited to the history of diseases in the motor system, nervous system, endocrine system, circulatory system, respiratory system, digestive system, urinary system, and reproductive system;
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 |
|---|---|---|
| [14C]HSK765325 mg of [14C]HSK7653 (radioactivity of 80 µCi) capsules are taken under fasted condition. | Drug | Arm Ⅰ |
Primary outcome
Percentage of cumulative drug excretion of [14C]HSK7653 on biological specimens(urine and faeces) accounting for total radiation drug dose
Time frame: From the start of administration to 50 day after administration
Though collecting different periods of biological specimens(urine and faeces) , detecting their respective drug excretion of [14C]HSK7653，calculating the total cumulative excretion amount and relevant proportion of each kind of specimen(urine or faeces).
Peak concentration (Cmax)
Time frame: From the start of administration to 50 day after administration
Pharmacokinetic Measures
Area under the concentration-time curve (AUC0-t, AUC0-∞)
Time frame: From the start of administration to 50 day after administration
Pharmacokinetic Measures
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 12 Dec 2022.
- Derived from this study: PubMed 38646838Bian YC, Meng J, Hu T, Ma S, Huang CR, Zhang FY, Wu QH, Zhang H, Chen XY, Miao LY. Biotransformation and disposition characteristics of HSK7653, a novel long-acting dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes. Diabetes Obes Metab. 2024 Jul;26(7):2860-2868. doi: 10.1111/dom.15605. Epub 2024 Apr 22.
- 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.
Liyan Miao, PhD principal investigator
Medical Ethics Committee of the First Affiliated Hospital of soochow University
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 [14C]HSK7653 in people with Type II Diabetes, run by Sichuan Haisco Pharmaceutical Group 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 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: finished, as of the sponsor's last update on 12 Dec 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?
Percentage of cumulative drug excretion of [14C]HSK7653 on biological specimens(urine and faeces) accounting for total radiation drug dose (time frame: From the start of administration to 50 day after administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04540016, which also lists 1 linked publication.
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 12 Dec 2022.