NCT07107672

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Jiangsu Sinorda Biomedicine Co., Ltd · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	[14C]X842	50 mg/100 µCi \[14C\] X842 suspension

Timeline

• Start date: 2022-06-15
• Primary completion: 2022-07-07
• Completion: 2022-11-14
• First posted: 2025-08-06
• Last updated: 2025-08-06

Locations

1 site across 1 country: China