HealthyPhase 1NCT06258746
Pharmacokinetics, Mass Balance, and Metabolism of [14C]HSK31679 in Healthy Adult Male Volunteers.
A Phase 1 study testing [14C]HSK31679 in people with Healthy, run by Xizang Haisco Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This is a single-center, nonrandomized, and open design study to investigate the pharmacokinetics, mass balance, metabolism and excretion of HSK31679 in healthy male subjects. 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
- What is being tested?
- [14C]HSK31679
- 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
- 5 Dec 2023to 30 Dec 2024
- 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 male subjects, Age: 18~45 years old (inclusive);
- A total body weight ≥50 kg and BMI of 19 to 26 kg/m^2(inclusive);
- Subjects who are willing to sign an informed consent form, able to communicate with the investigator and to complete all trial procedures as per the protocol.
Who cannot join
- Clinically significant abnormal results for comprehensive physical examination, vital signs, routine laboratory tests [blood routine, blood biochemistry, coagulation routine, urine routine, Fecal analysis, thyroid function and antibodies, 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, 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;
- Any clinical serious illness that has previously or currently affected the cardiovascular system, digestive system, respiratory system, endocrine system, nervous system, hematology, immunology, skin, tumors, psychiatry, and metabolic abnormalities, or any other disease or physiological condition that can interfere with trial results;
- 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);
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- Severe allergic constitution, including known allergy to THR- β receptor agonists or any excipient of this investigational product, two or more drugs and food components, or with special dietary requirements and thus unable to follow a standardized diet;
- Concomitant hemorrhoids or perianal diseases with regular/ongoing rectal bleeding;
- Subjects who had Irregular bowel movements or diarrhea, irritable bowel syndrome, inflammatory bowel disease;
- Excessive drinking or frequent drinking within the first 6 months of the screening period, i.e. drinking more than 14 units of alcohol per week (1 unit=360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine); Positive alcohol breath test during the screening period;
- Subjects who smoked more than 5 cigarettes a day or habitually used nicotine-containing products in the 3 months before the screening period and could not quit during the test period;
- Drug abuse or dependence, urine screening positive for drug abuse;
- Habitually drinking grapefruit juice or excessive (more than 8 cups a day, 1 cup =250mL) tea, grapefruit, coffee, drinks containing caffeine or grapefruit, and could not quit during the test period;
- Subjects who need to work in a condition with long-term radioactive exposure; or who have experienced significant radioactive exposure (≥2 chest/abdominal CT scans, or ≥3 other types of X-rays) within 1 year or participated in the radiopharma labeling test prior to the test;
- Subjects who have a birth plan during the study period and within 1 year after completion of the study, or who don't agree that the subject and his or her spouse should take strict contraceptive measures (condoms, contraceptive sponges, contraceptive gels, contraceptive membranes, intrauterine devices, oral or injectable contraceptives, subcutaneous implants, etc.) during the study period and within 1 year after completion of the study;
- Subjects who have experienced blood loss or donated 400 mL of blood within the first 3 months of the screening period, or have received blood transfusions within 1 month;
- 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.
China1 site
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong
About this study
Official title: A Clinical Study on Absorption, Metabolism, and Excretion of [14C]HSK31679 in Healthy Adult Male Chinese Subjects - Mass Balance and Biotransformation of [14C]HSK31679 in Human
This is a single-center, nonrandomized, and open design study to investigate the pharmacokinetics, mass balance, metabolism and excretion of HSK31679 in healthy male subjects.
- Conditions
- Healthy
- Being tested
- [14C]HSK31679
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]HSK31679Drug
A single oral dose of 160 mg/100 μCi [14C]HSK31679 after fasting for at least 10 hours.
| Study group | Role | What they receive |
|---|---|---|
| 160 mg/100 μCi [14C]HSK31679 | Experimental | [14C]HSK31679 Receives: Drug: [14C]HSK31679 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance
Percentage of cumulative drug excretion of [14C]HSK31679 on biological pecimens(urine and faeces) accounting for total radiation drug dose
Measured: From the start of administration to 240 hours after administration
Secondary outcomes (3)
AUC(0-t)
The pharmacokinetic parameters of HSK31679 and major metabolites (if applicable) in plasma
Measured: From the start of administration to 240 hours after administration
AUC(0-∞)
The pharmacokinetic parameters of HSK31679 and major metabolites (if applicable) in plasma
Measured: From the start of administration to 240 hours after administration
Cmax
The pharmacokinetic parameters of HSK31679 and major metabolites (if applicable) in plasma
Measured: From the start of administration to 240 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start5 Dec 2023
- Primary completion21 Dec 2023
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xizang Haisco Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258746
- Sponsor's protocol ID
- HSK31679-102
- Status last verified
- Jan 2024
- First submitted
- 6 Feb 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on Absorption, Metabolism, and Excretion of [14C]HSK31679 in Healthy Adult Male Chinese Subjects - Mass Balance and Biotransformation of [14C]HSK31679 in Human
- ClinicalTrials.gov ID
- NCT06258746
- Acronym / sponsor ID
- HSK31679-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Xizang Haisco Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 14 Feb 2024 (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, nonrandomized, and open design study to investigate the pharmacokinetics, mass balance, metabolism and excretion of HSK31679 in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 160 mg/100 μCi [14C]HSK31679 | Experimental | Drug: [14C]HSK31679[14C]HSK31679 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects, Age: 18~45 years old (inclusive);
- A total body weight ≥50 kg and BMI of 19 to 26 kg/m^2(inclusive);
- Subjects who are willing to sign an informed consent form, able to communicate with the investigator and to complete all trial procedures as per the protocol.
Key exclusion criteria (17 listed)
- Clinically significant abnormal results for comprehensive physical examination, vital signs, routine laboratory tests [blood routine, blood biochemistry, coagulation routine, urine routine, Fecal analysis, thyroid function and antibodies, 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, 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;
- Any clinical serious illness that has previously or currently affected the cardiovascular system, digestive system, respiratory system, endocrine system, nervous system, hematology, immunology, skin, tumors, psychiatry, and metabolic abnormalities, or any other disease or physiological condition that can interfere with trial results;
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]HSK31679A single oral dose of 160 mg/100 μCi [14C]HSK31679 after fasting for at least 10 hours. | Drug | 160 mg/100 μCi [14C]HSK31679 |
Primary outcome
Mass balance
Time frame: From the start of administration to 240 hours after administration
Percentage of cumulative drug excretion of [14C]HSK31679 on biological pecimens(urine and faeces) accounting for total radiation drug dose
3 secondary outcomes
AUC(0-t)
Time frame: From the start of administration to 240 hours after administration
AUC(0-∞)
Time frame: From the start of administration to 240 hours after administration
Cmax
Time frame: From the start of administration to 240 hours after administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
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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 [14C]HSK31679 in people with Healthy, run by Xizang Haisco Pharmaceutical 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 17 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 20 Aug 2024. 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?
Mass balance (time frame: From the start of administration to 240 hours after administration). 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 20 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.