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

NCT07107672 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-08-06

No results posted yet for this study

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

Interventions

DRUG

[14C]X842

50 mg/100 µCi \[14C\] X842 suspension

Sponsors & Collaborators

  • Jiangsu Sinorda Biomedicine Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Huan Zhou · The First Affiliated Hospital of Bengbu Medical University

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2022-07-07
Completion
2022-11-14

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07107672 on ClinicalTrials.gov