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

NCT07107672 | Completed Phase 1

• 1 other identifier: SND-X842-102
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastroesophageal Reflux Disease

Keywords

Reflux Esophagitis; X842; Pharmacokinetics, PK; [14C]X842; linaprazan

Outcome Measures

Primary Outcomes (9)

• Mass balance: the cumulative excretion rate

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

  22 days

• Tmax (time to maximum observed concentration)

  Tmax parameters of the total radioactivity in plasma

  22 days

• Cmax(maximum concentration)

  Cmax parameters of the total radioactivity in plasma

  22 days

• AUC(area under curve)

  AUC parameters of the total radioactivity in plasma

  22 days

• t1/2 (terminal elimination half-life)

  t1/2 parameters of the total radioactivity in plasma

  22 days

• MRT (mean residence time)

  MRT parameters of the total radioactivity in plasma

  22 days

• Vd/F(apparent volume of distribution)

  Vd/F parameters of the total radioactivity in plasma

  22 days

• 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

  22 days

• 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

  22 days

Secondary Outcomes (12)

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

  22 days

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

  22 days

• 12-Electrocardiograms (ECG)

  22 days

• vital signs of pulse

  22 days

• vital signs of body temperature

  22 days

Study Arms (1)

[14C]X842 suspension approximately 50 mg/ 100 µCi[14C]X842

EXPERIMENTAL

a single oral administration of approximately 50 mg/ 100 µCi \[14C\]X842 suspension orally on an empty stomach on day 1

Drug: [14C]X842

Interventions

[14C]X842 DRUG

50 mg/100 µCi \[14C\] X842 suspension

Also known as: [14C]X842 suspension

[14C]X842 suspension approximately 50 mg/ 100 µCi[14C]X842

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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;
• 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;

Sponsors & Collaborators

• Jiangsu Sinorda Biomedicine Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233099, China

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Esophagitis, Peptic

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophagitis; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Study Officials

• Huan Zhou

  The First Affiliated Hospital of Bengbu Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study plans to enroll 6 to 8 healthy male subjects in China to ensure at least 4 evaluable subjects

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 6, 2025
• Study Start: June 15, 2022
• Primary Completion: July 7, 2022
• Study Completion: November 14, 2022
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

CN (1)