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HealthyPhase 1NCT06569784

Mass Balance Study of [14C]HSK31858 in Healthy Adult Male Chinese Subjects.

A Phase 1 study testing [14C]HSK31858 in people with Healthy, run by Xizang Haisco Pharmaceutical Co., Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single-center, nonrandomized, and open design study to investigate the pharmacokinetics, mass balance, metabolism and excretion of HSK31858 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]HSK31858
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
30 May 2024to 30 Oct 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 Chinese male subjects, Age: 18~45 years old (inclusive);
  • Body weight ≥50.0 kg and BMI of 19 to 26 kg/m^2(inclusive);
  • Subjects who voluntarily signed the informed consent form, are able to communicate with the investigator and complete all study procedures as per the protocol.

Who cannot join

  • Clinical examination:
  • After physical examination, vital signs, laboratory tests (hematology, blood biochemistry, coagulation, urinalysis, stool analysis + occult blood, thyroid function), ophthalmological examination (slit lamp, intraocular pressure and fundus photography), 12-lead electrocardiogram [Fridericia-corrected QT (QTcF)-interval, which in men should be between 350-450ms (inclusive)], chest X-ray (PA and lateral), and abdominal ultrasound (liver, gallbladder, pancreas, spleen, kidney) are abnormal and clinically significant;
  • Subjects tested positive for hepatitis B surface antigen or E antigen, hepatitis C antibody, combined human immunodeficiency virus antigen/antibody (HIV-Ag/Ab), or Treponema pallidum antibody;
  • Medication history:
  • Subjects who have used prescription, over-the-counter, or healthcare drugs, including Western or proprietary Chinese medicines, within 14 days or 5 half-lives of the drug, whichever is longer, prior to screening;
  • Subjects who have articipated in any clinical trial and received test drug or medical device intervention within 3 months prior to screening;
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  • Anyone who has used any drug that inhibits or induces CYP3A activity or P-gp inhibitors within 30 days prior to screening;
  • Disease history and surgical history:
  • Prior or current history of any clinically serious disease of the cardiovascular, digestive, respiratory, endocrine, neurological, haematological, immunological, dermatological, oncological, psychiatric, and metabolic abnormalities or any other disease or physiological condition capable of interfering with the study results;
  • History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsades de pointes, ventricular tachycardia, atrioventricular block, QT prolongation syndrome, or symptoms of QT prolongation syndrome, or a family history of the disease (as evidenced by genetic predisposition or a close relative's sudden death from cardiac causes at a young age);
  • Subjects with a previous diagnosis of periodontitis or/and palmoplantar hyperkeratosis who are screened with the following problems:
  • Subjects with current signs of gingivitis/periodontitis;
  • Subjects with a history of hyperkeratosis of the palms or soles or erythema;
  • Subjects who had major surgery or incompletely healed surgical incisions within 6 months prior to the screening, including, but not limited to, any surgery with significant risk of bleeding, prolonged general anaesthesia or incisional biopsy, or significant traumatic injury (with the exception of healed surgery of appendicitis or prolapse of the anus);
  • Subjects with hyperactive immune response, including: clear sensitive to DPP1 inhibitors or any excipients of the drug in this trial, allergy to two or more other drugs or food ingredients or special dietary requirements and inability to comply with a uniform diet;
  • Comorbidities with haemorrhoids or perianal disease with regular/ongoing blood in stool, irritable bowel syndrome, inflammatory bowel disease;
  • Lifestyle habits:
  • Irregular bowel movements or diarrhoea;
  • Alcohol abuse or frequent alcohol drinking within 6 months prior to screening, that is, > 14 units of alcohol consumption per week (1 unit = 360 mL beer or 45 mL of liquor with 40% alcohol or 150 mL wine), or positive result for breath alcohol test at screening;
  • Subjects who smoke more than 5 cigarettes a day or have habitual use of nicotine containing products within 3 months prior to screening and fail to quit smoking during the trial;
  • Subjects with a long history of drug abuse or dependence with a positive urine screen for drug abuse;
  • Subjects with habitual consumption of grapefruit juice or excessive tea (more than 8 cups a day, 1 cup = 250mL), excessive caffeine (more than 3 cups of coffee a day, etc.) that cannot be stopped during the trial;
  • Other:
  • Subjects who engage in work requiring long-term exposure to radioactive conditions; or those with significant radioactive exposure within 1 year prior to the trial (≥ 2 chest/abdominal CT, or ≥ 3 other types of X-ray tests); or those who have participated in radiopharmaceutical studies within 1 year;
  • Subjects with a history of fainting during acupuncture or blood phobia, difficulty in collecting blood, or inability to tolerate blood collection by venipuncture;
  • The presence of tattoos or scars on any part of the skin that, in the judgement of the investigator, interfere with the safety assessment;
  • Subjects having a birth plan during the trial and in 1 year after trial completion, or subjects or their spouses who refuse to take rigorous contraceptive measures (including use of condoms, contraceptive sponges, contraceptive gels, contraceptive diaphragms, intrauterine devices, oral or injectable contraceptives, contraceptive implants, etc.) during the trial and in 1 year after trial completion;
  • Subjects who had blood loss or blood donation of up to 400 mL in 3 months prior to screening, or who had received blood transfusion in 1 month prior to screening;
  • Subjects unsuitable for participating in this trial for any other reason as judged by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000

Other trials in China

About this study

Official title: A Clinical Study on Absorption, Metabolism, and Excretion of [14C]HSK31858 in Healthy Adult Male Chinese Subjects - Mass Balance and Biotransformation of [14C]HSK31858 in Human.

This is a single-center, nonrandomized, and open design study to investigate the pharmacokinetics, mass balance, metabolism and excretion of HSK31858 in healthy male subjects.

Conditions
Healthy
Being tested
[14C]HSK31858

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]HSK31858Drug

    A single oral dose of 40 mg/120 μCi [14C]HSK31858 after fasting for at least 10 hours.

Study groups in NCT06569784
Study groupRoleWhat they receive
40 mg/120 μCi[14C]HSK31858Experimental[14C]HSK31858
Receives: Drug: [14C]HSK31858

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total radioactivity ecovery rates in urine

    Total radioactivity ecovery rates in urine at each time interval.

    Measured: during periods of 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, 24-48 hours, 48-72 hours, 72-96 hours, 96-120 hours, 120-144 hours, 144-168 hours, 168-192 hours, 192-216 hours, 216-240 hours, 240-264 hours, 264-288 hours, and 288-312 hours post-dose

  2. Total radioactivity ecovery rates in feces

    Total radioactivity ecovery rates in feces at each time interval.

    Measured: during periods of 0-24 hours, 24-48 hours, 48-72 hours, 72-96 hours, 96-120 hours, 120-144 hours, 144-168 hours, 168-192 hours, 192-216 hours, 216-240 hours, 240-264 hours, 264-288 hours, and 288-312 hours post-dose

  3. Cumulative total radioactivity recovery rates

    Cumulative total radioactivity recovery rates of [14C]HSK31858 in excretion (urine and faeces) accounting for total radiation drug dose.

    Measured: From the start of administration to 312 hours post-dose

  4. Cmax of total radioactivity

    The pharmacokinetic parameters of total radioactivity in plasma

    Measured: From the start of administration to 312 hours post-dose

  5. AUC(0-t) of total radioactivity

    The pharmacokinetic parameters of total radioactivity in plasm

    Measured: From the start of administration to 312 hours post-dose

  6. AUC(0-∞) of total radioactivity

    The pharmacokinetic parameters of total radioactivity in plasm

    Measured: From the start of administration to 312 hours post-dose

  7. %AUC

    Human plasma parent drug and its metabolites as a percentage of total plasma radioactivity exposure

    Measured: From the start of administration to 312 hours post-dose

  8. % administered dose

    Human urine and feces parent drug and its metabolites as a percentage of administered dose

    Measured: From the start of administration to 312 hours post-dose

  9. Identification of the main metabolites

    Identification of the main metabolites of HSK31858 in plasma, urine, and feces.

    Measured: From the start of administration to 312 hours post-dose

Secondary outcomes (7)

  1. AUC(0-t)

    The pharmacokinetic parameters of the parent drug HSK31858, metabolite M4 and other metabolites (if applicable) in plasma

    Measured: From the start of administration to 312 hours post-dose

  2. AUC(0-∞)

    The pharmacokinetic parameters of the parent drug HSK31858, metabolite M4 and other metabolites (if applicable) in plasma

    Measured: From the start of administration to 312 hours post-dose

  3. Cmax

    The pharmacokinetic parameters of the parent drug HSK31858, metabolite M4 and other metabolites (if applicable) in plasma

    Measured: From the start of administration to 312 hours post-dose

  4. Tmax

    The pharmacokinetic parameters of the parent drug HSK31858, metabolite M4 and other metabolites (if applicable) in plasma

    Measured: From the start of administration to 312 hours post-dose

  5. t1/2

    The pharmacokinetic parameters of the parent drug HSK31858, metabolite M4 and other metabolites (if applicable) in plasma

    Measured: From the start of administration to 312 hours post-dose

  6. Mean Residence Time

    The pharmacokinetic parameters of the parent drug HSK31858, metabolite M4 and other metabolites (if applicable) in plasma

    Measured: From the start of administration to 312 hours post-dose

  7. AEs

    The incidence and severity of AEs

    Measured: From the time of signing ICF to the end of follow-up，up to 14 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2024
  2. Study start30 May 2024
  3. Primary completion2 Jul 2024
  4. Study completion30 Oct 2024 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06569784
Sponsor's protocol ID
HSK31858-103
Status last verified
Aug 2024
First submitted
19 Aug 2024
Last updated
26 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]HSK31858 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 29 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 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?

Total radioactivity ecovery rates in urine (time frame: during periods of 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, 24-48 hours, 48-72 hours, 72-96 hours, 96-120 hours, 120-144 hours, 144-168 hours, 168-192 hours, 192-216 hours, 216-240 hours, 240-264 hours, 264-288 hours, and 288-312 hours post-dose). The study lists 9 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 NCT06569784.

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 Aug 2024.

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