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Healthy SubjectsPhase 1NCT05883306

Mass Balance and Biotransformation Study of [14C]LXI-15028 in Humans

A Phase 1 study testing [14C]LXI-15028 in people with Healthy Subjects and Pharmacokinetics of 14C-labeled of LXI-15028, run by Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess absorption, metabolism and excretion of [14C]-LXI-15028 in Chinese healthy male Subjects following a single oral dose of [14C]LXI-15028 suspension. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
What is being tested?
[14C]LXI-15028
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 Jun 2022to 23 Dec 2022
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

  • Chinese healthy male subjects;
  • 18 to 45 years of age (inclusive)
  • Body mass index (BMI) of 19-26 kg/m2 (inclusive), and body weight not less than 50 kg (inclusive)
  • Voluntarily signing the ICF
  • Ability to communicate well with the investigator and compliance to complete the trial according to the protocol.

Who cannot join

  • Clinically significant abnormality of physical examination, vital signs, routine laboratory tests (hematology, blood chemistry, coagulation, urinalysis, stool routine + occult blood, and thyroid function), 12-lead ECG, chest CT, and abdomen ultrasound (liver, gallbladder, pancreas, spleen, and kidneys), etc.
  • Resting QT interval (QTcF) ≥ 450 ms by 12-lead electrocardiogram (ECG)
  • Hepatitis B surface antigen or hepatitis B e antigen test, hepatitis C virus antibody IgG test, human immunodeficiency virus antigen/antibody combination test, or Treponema pallidum antibody test is positive
  • Novel coronavirus infection screening shows C-reactive protein is clinically significant abnormality, or COVID-19 nucleic acid test is positive
  • Use of any drugs inhibiting or inducing hepatic drug metabolizing enzymes within 30 days before screening;
  • Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or dietary supplements such as vitamins and calcium supplements within 14 days before screening;
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  • History of any clinical critical illness or presence of diseases or conditions that the investigator considers may affect the trial results, including but not limited to diseases of cardiovascular system, circulatory system, respiratory system, endocrine system, nervous system, digestive system, urinary system or blood, immune system, and psychiatric system, especially metabolism and nutrition diseases and gastrointestinal diseases;
  • Major surgery within 6 months before screening or incomplete healing of surgical incision, the major surgeries including but not limited to any procedures that have significant risk of hemorrhage, prolonged general anesthesia, open biopsy, or marked traumatic invasive injury;
  • Subjects with an allergic constitution (e.g., history of bronchial asthma, allergy to food and pollen, allergy to two or more drugs, or history of allergy), including any previous serious adverse reaction to proton pump inhibitors or potassium-competitive acid blockers (e.g., omeprazole, rabeprazole, lansoprazole, and vonoprazan), or known hypersensitivity to penicillin or cephalosporin antibiotics; or those who may be hypersensitive to the investigational drug or its excipients, as judged by the investigator;
  • Hemorrhoids or perianal diseases with regular/current hematochezia, irritable bowel syndrome, and inflammatory bowel disease;
  • Habitual constipation or diarrhea;
  • Alcoholism or frequent alcohol use within 6 months before screening, i.e., weekly alcohol consumption > 14 units (1 unit = 360 mL of beer or 45 mL of ABV 40% spirit or 150 mL of wine); or positive alcohol breath test result at Screening;
  • Daily smoking exceeding 5 cigarettes (≥ 5 cigarettes) within 3 months before Screening, or habitual use of nicotine-containing products and inability to withdraw during the trial period;
  • Drug abuse, use of soft drug (e.g., marijuana) within 3 months before screening, or use of hard drug (e.g., cocaine, amphetamines, phencyclidine, etc.) within 1 year before screening; or positive urine drug test at screening;
  • Drinking excessive tea, coffee and/or caffeine-containing beverages (over 8 cups, 1 cup = 250 mL) on a daily basis within 3 months prior to screening;
  • Inability to avoid intake of grapefruit, bitter orange, starfruit, pithya, mango, and other fruit or fruit juice that may affect the metabolism from 7 days before administration until completion of the study;
  • Work with long-term exposure to radioactive conditions; or marked exposure to radioactivity (chest/abdomen CT ≥ 2 times, or other kinds of X-ray examinations ≥ 3 times) or participation in any radioactive labeling trial within 1 year before the trial;
  • History of fear of needles and blood, difficult blood sampling, or incapability of tolerating blood sampling via venipuncture;
  • Participation in any other clinical trial (including drug and device clinical trials) within 3 months before screening;
  • Vaccination within 1 month before Screening or planned vaccination during the trial period;
  • Subjects who have a plan for parenthood or sperm donation from the signing of informed consent to 1 year following the completion of the trial, or those who do not agree that subjects and their partners should use strict contraception from the signing of informed consent to 1 year following the completion of the trial;
  • Blood loss or blood donation up to 400 mL (≥ 400 mL) within 3 months before Screening, or blood transfusion within 1 month before screening;
  • Subjects who have any factors that make them not suitable for participating in this trial, as assessed by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

Other trials in China

About this study

Official title: A Clinical Trial to Assess Absorption, Metabolism and Excretion of [14C]-LXI-15028 in Chinese Healthy Male Subjects - Mass Balance and Biotransformation Study of [14C]LXI-15028 in Humans

To assess absorption, metabolism and excretion of [14C]-LXI-15028 in Chinese healthy male Subjects following a single oral dose of [14C]LXI-15028 suspension.

Being tested
[14C]LXI-15028

What participants receive

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

  • [14C]LXI-15028Drug

    [14C]LXI-15028

Study groups in NCT05883306
Study groupRoleWhat they receive
[14C]LXI-15028(n=6-8)ExperimentalSubjects will receive a single oral dose of [14C]LXI-15028 suspension under the fasted state .
Receives: Drug: [14C]LXI-15028

What is being measured

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

  1. Mass balance

    Mass balance recovery of total radioactivity in urine and fecal samples

    Measured: approximately 11 days

  2. Metabolite Profiling

    To provide plasma, urine and faecal samples for metabolite profiling and structural identification

    Measured: approximately 11 days

  3. Total radioactivity in plasma PK:Tmax

    Time for Cmax

    Measured: approximately 11 days

  4. Total radioactivity in plasma PK:AUC0-t

    Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration.

    Measured: approximately 11 days

  5. Total radioactivity in plasma PK:t1/2

    Elimination half-life.

    Measured: approximately 11 days

  6. Total radioactivity in plasma PK:CL/F

    Drug clearance

    Measured: approximately 11 days

  7. Total radioactivity in plasma PK:Vd/F

    Apparent volume of distribution following oral administration

    Measured: approximately 11 days

  8. LXI-15028 and metabolite PK:Cmax

    Maximum plasma concentration

    Measured: approximately 11 days

  9. LXI-15028 and metabolite PK:Tmax

    Time for Cmax

    Measured: approximately 11 days

  10. LXI-15028 and metabolite PK:AUC0-t

    Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration.

    Measured: approximately 11 days

  11. LXI-15028 and metabolite PK:AUC0-inf

    Area under the plasma concentration time profile from time 0 to infinity.

    Measured: approximately 11 days

  12. LXI-15028 and metabolite PK:t1/2

    Elimination half-life.

    Measured: approximately 11 days

  13. LXI-15028 and metabolite PK:CL/F

    Drug clearance

    Measured: approximately 11 days

  14. LXI-15028 and metabolite PK:Vd/F

    Apparent volume of distribution following oral administration

    Measured: approximately 11 days

Secondary outcomes (1)

  1. Adverse events

    Number of adverse events, which are any untoward medical occurrence regardless of attribution to study drug in a participant who received study drug

    Measured: approximately 11 days

Timeline

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

  1. First posted31 May 2023
  2. Study start30 Jun 2022
  3. Primary completion21 Jul 2022
  4. Study completion23 Dec 2022

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
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05883306
Sponsor's protocol ID
NE822201
Status last verified
May 2023
First submitted
10 May 2023
Last updated
31 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bian Y, Yuan J, Ma S, Nan J, Gu Z, Feng H, Yu Z, Liu Z, Xie F, Wang Y, Liu C, Zhang H, Miao L. Mass balance and metabolite profiles in humans of tegoprazan, a novel potassium-competitive acid blocker, using 14C-radiolabelled techniques. Expert Opin Drug Metab Toxicol. 2025 Jul;21(7):897-907. doi: 10.1080/17425255.2025.2505637. Epub 2025 May 13.

    PubMed 40349123

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]LXI-15028 in people with Healthy Subjects and Pharmacokinetics of 14C-labeled of LXI-15028, run by Shandong Luoxin Pharmaceutical Group Stock 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 5 inclusion and 23 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 31 May 2023. 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?

Mass balance (time frame: approximately 11 days). The study lists 14 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 NCT05883306, 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 31 May 2023.

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