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Gastroesophageal Reflux DiseasePhase 1NCT07107672

Mass Balance Study of [14C]X842 in Healthy Adult Male Subjects

A Phase 1 study testing [14C]X842 in people with Gastroesophageal Reflux Disease, run by Jiangsu Sinorda Biomedicine 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

This study is a single-site, single-dose, non-randomized, open-label study to assess the absorption, metabolism, and excretion profile of [14C]X842 in healthy adult male subjects. The study plans to enroll 6 to 8 healthy male subjects in China to ensure at least 4 evaluable 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
Gastroesophageal Reflux Disease
What is being tested?
[14C]X842
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 Jun 2022to 14 Nov 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

  • Healthy adult males;
  • Age: 18 to 45 years (inclusive)
  • Body weight: ≥50 kg with body mass index (BMI) between 19.0 and 26.0 kg/m² (inclusive);
  • Fully understand the trial objectives, requirements, procedures, and potential adverse reactions; voluntarily participate; able to complete the study per protocol and comply with regulations; informed consent obtained in compliance with GCP;
  • The subjects were able to communicate well with the researchers and complete the trial in accordance with the provisions of the protocol.

Who cannot join

  • Auxiliary Examinations:
  • Subjects with abnormal and clinically significant findings in Physical examination, Vital signs, Laboratory tests (including hematology, blood biochemistry, coagulation, urinalysis, fecal occult blood),Thyroid function, 12-lead ECG, Anteroposterior chest X-ray, Abdominal ultrasound, and/or other clinically relevant investigations;
  • Subjects testing positive for: Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV-Ab), Human immunodeficiency virus antibody (HIV-Ab),Treponema pallidum antibody (syphilis screening);
  • -Medication History:
  • Subjects with use of any medications known to inhibit or induce hepatic drug-metabolizing enzymes within 30 days prior to screening；
  • Subjects with use of any prescription medications, over-the-counter drugs, Chinese herbal medicines, or dietary supplements (e.g., vitamins, calcium) within 14 days prior to screening;
Show all 25Show fewer
  • -Disease and Surgical History
  • History of any clinically significant disease or condition that the investigator deems may affect the trial results, including but not limited to diseases of the circulatory, respiratory, endocrine, nervous, digestive, urinary systems, or blood, immune, psychiatric, and metabolic disorders;
  • History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsade de pointes, ventricular tachycardia, atrioventricular block, long QT syndrome, or family history thereof (as evidenced by genetic confirmation or sudden cardiac death of close relatives at a young age);
  • Major surgery within 6 months prior to screening, or incompletely healed surgical wounds; Major surgery includes, but is not limited to, any procedure with significant bleeding risk, prolonged general anesthesia, open biopsy, or significant traumatic injury;
  • Subjects have prone to allergies, such as a known history of hypersensitivity to two or more substances; or individuals deemed by the investigator as potentially allergic to the trial drug or its excipients;
  • Subjects with regular/ongoing hematochezia, irritable bowel syndrome, inflammatory bowel disease;
  • -life style
  • Subjects with habitual constipation or diarrhea;
  • Subjects who has the history of alcoholism or regular alcohol consumption within 6 months prior to screening, defined as consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine), and inability to abstain during the trial period; or a breath alcohol test result ≥ 0 mg/dL at screening;
  • Subjects who have smoked more than 5 cigarettes per day or habitually using nicotine-containing products within 3 months prior to screening, or who are unable to stop using any tobacco products during the trial;
  • Subjects who have a history of drug abuse within three months prior to the screening period or whose urine test for prohibited drugs (morphine, methamphetamine, ketamine, dimethylene dioxyethanol, tetrahydrocannabinic acid) is positive during the screening;
  • Subjects who has habitually consumption of grapefruit juice or excessive amounts of tea, coffee and/or caffeinated beverages and are unable to quit during the trial period;
  • Subjects who are exposed to radioactive work conditions for a long time, or have significant radiation exposure (≥ 2 chest/abdominal CTs, or ≥ 3 other types of X-ray examinations) within 1 year before the first dose, or have participated in a radiopharmaceutical labeled trial;
  • Subjects with a history of blood or needle phobia, and those who have difficulty in blood collection or cannot tolerate venipuncture blood collection;
  • Subjects have participated in any other clinical trial (including trials of investigational drugs or medical devices, etc.) within 3 months prior to the screening period.
  • Subjects who have received any vaccination within 1 month prior to screening or plan to receive any vaccination during the study period;
  • subjects who plan to conceive or donate sperm during the trial period or within 1 year after trial completion, or those who do not agree that the subject and their partner must use highly effective contraception during the trial period and for 1 year after trial completion;
  • Subjects who have lost blood or donated blood (200mL), or received blood transfusions within 3 month before the screening period.
  • Subjects who are unsuitable for the study participation for other reasons at the discretion of the investigator;

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233099

Other trials in China

About this study

Official title: Mass Balance and Biotransformation Study of [14C]X842 in Healthy Adult Male Subjects in China

This study is a single-site, single-dose, non-randomized, open-label study to assess the absorption, metabolism, and excretion profile of [14C]X842 in healthy adult male subjects. The study plans to enroll 6 to 8 healthy male subjects in China to ensure at least 4 evaluable subjects.

Read the detailed description

The healthy male subjects will be screened no more than 14 days before the dose (D-14 through D-3) and admitted to the clinical research center 2 days before the dose (D-2). The subjects will receive a single oral administration of approximately 50 mg/100 µCi [14C]X842 suspension orally on an empty stomach on day 1.

Urine and feces samples will be all collected from the subjects before and at specified intervals between 0 and 312 hours after taking the drug and blood samples will be collected at specified time points between 0 and 216 hours before and after taking the drug.

Being tested
[14C]X842
Keywords
Reflux Esophagitis, X842, Pharmacokinetics, PK, [14C]X842, linaprazan
Medical subject headings
Gastroesophageal Reflux, Esophagitis, Peptic

What participants receive

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

  • [14C]X842Drug

    Also called [14C]X842 suspension

    50 mg/100 µCi [14C] X842 suspension

Study groups in NCT07107672
Study groupRoleWhat they receive
[14C]X842 suspension approximately 50 mg/ 100 µCi[14C]X842Experimentala single oral administration of approximately 50 mg/ 100 µCi [14C]X842 suspension orally on an empty stomach on day 1
Receives: Drug: [14C]X842

What is being measured

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

  1. Mass balance: the cumulative excretion rate

    To collect the total radioactive substances in excreta (urine and feces) and to calculate the cumulative excretion rate

    Measured: 22 days

  2. Tmax (time to maximum observed concentration)

    Tmax parameters of the total radioactivity in plasma

    Measured: 22 days

  3. Cmax(maximum concentration)

    Cmax parameters of the total radioactivity in plasma

    Measured: 22 days

  4. AUC(area under curve)

    AUC parameters of the total radioactivity in plasma

    Measured: 22 days

  5. t1/2 (terminal elimination half-life)

    t1/2 parameters of the total radioactivity in plasma

    Measured: 22 days

  6. MRT (mean residence time)

    MRT parameters of the total radioactivity in plasma

    Measured: 22 days

  7. Vd/F(apparent volume of distribution)

    Vd/F parameters of the total radioactivity in plasma

    Measured: 22 days

  8. whole blood/plasma ratio for the total radioactivity concentration at different time points

    whole blood/plasma ratio for the total radioactivity concentration at different time points

    Measured: 22 days

  9. Percentage of the drug and its metabolites in plasma, urine and feces to the administered dose

    Exposure in plasma; percentage of the drug and its metabolites in urine and feces to the administered dose; identification of major metabolites in plasma, urine and feces

    Measured: 22 days

Secondary outcomes (12)

  1. The nature and severity of AEs based on NCI-CTC AE V5.0

    The nature and severity of adverse events were adjudicated in accordance with the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0)

    Measured: 22 days

  2. The nature and incidence and severity of SAEs based on NCI-CTC AE V5.0

    The nature and severity of serious adverse events were adjudicated in accordance with the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0)

    Measured: 22 days

  3. 12-Electrocardiograms (ECG)

    the data collection of heart rate, PR interval, QRS interval, QT, QTc, on D-1 and 2 hours (±30 min) after administration

    Measured: 22 days

  4. vital signs of pulse

    pulse (beats per minute)

    Measured: 22 days

  5. vital signs of body temperature

    body temperature (℃)

    Measured: 22 days

  6. vital signs of blood pressure

    measurements included systolic (mmHg) and diastolic (mmHg).

    Measured: 22 days

  7. vital signs of respiratory rate

    respiratory rate (breaths per minute).

    Measured: 22 days

  8. Hematology - Number of participants with clinically significant abnormalities

    including White blood cell count, lymphocyte count, neutrophil count, red blood cell count, hemoglobin, platelet count

    Measured: 22 days

  9. Blood Chemistry - Number of participants with clinically significant abnormalities

    Blood Biochemistry including: Total Bilirubin (TBIL), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-Glutamyl Transferase (GGT), Alkaline Phosphatase (ALP), Total Protein (TP), Albumin (ALB), Urea, Creatinine (Cr), Uric Acid (UA), Glucose (GLU), Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Low-Density Lipoprotein Cholesterol (LDL-C), Triglycerides (TG), Potassium (K+), Sodium (Na+), Chloride (Cl-), Lactate Dehydrogenase (LDH), Creatine Kinase (CK), Amylase (AMY).

    Measured: 22 days

  10. Coagulation - Number of participants with clinically significant abnormalities

    including Prothrombin Time (PT), Thrombin Time (TT), Activated Partial ,, hromboplastin Time (APTT/aPTT)，Fibrinogen (FIB/Fg), International Normalized Ratio (INR)

    Measured: 22 days

  11. Urinalysis - Number of participants with clinically significant abnormalities

    Urinalysis including Urinary protein, urine sugar, urine ketone bodies, red blood cells, white blood cells, pH value

    Measured: 22 days

  12. Fecal Occult Blood Test (FOBT) - Number of participants with positive result

    Fecal Occult Blood Test (FOBT) result

    Measured: 22 days

Timeline

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

  1. First posted6 Aug 2025
  2. Study start15 Jun 2022
  3. Primary completion7 Jul 2022
  4. Study completion14 Nov 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
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
The study plans to enroll 6 to 8 healthy male subjects in China to ensure at least 4 evaluable subjects
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07107672
Sponsor's protocol ID
SND-X842-102
Status last verified
Aug 2025
First submitted
14 Jul 2025
Last updated
6 Aug 2025
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]X842 in people with Gastroesophageal Reflux Disease, run by Jiangsu Sinorda Biomedicine 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 25 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 6 Aug 2025. 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: the cumulative excretion rate (time frame: 22 days). 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 NCT07107672.

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 6 Aug 2025.

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