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
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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