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NCT06352190

A Study to Evaluate the Mass Balance of [14C] SY-5007 in Healthy Adult Male Subjects in China

An Open-Label, Single-Center, Single-Dose, Phase I Study to Assess the Mass Balance of [14C] SY-5007 in Healthy Male Subjects in China
Shouyao Holdings (Beijing) Co. LTD·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Healthy Subjects
Drug/Device/Intervention
[14C] SY-5007
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Shouyao Holdings (Beijing) Co. LTD
Location
Beijing, China
Timeline & enrollment
Phase
Phase 1
Start date
May 01, 2024
End date
Jun 01, 2024
Enrollment
8 participants
Primary outcome

Total radioactivity in plasma PK: Cmax,Total radioactivity in plasma PK: Tmax,Total radioactivity in plasma PK: AUC0-t,Total radioactivity in plasma PK: t½,Total radioactivity in plasma PK: CL/F,Whole blood to plasma total radioactivity ratio,Cumulative total radioactivity in urine and faeces,Metabolic profiling in plasma, urinary and fecal excretion

Summary

This is a single-center, open-label, non-randomized, single dose study in healthy male
 subjects designed to assess mass balance recovery, metabolite profile and metabolite
 identification of radio-labeled SY-5007 administered orally.

ICD-10 classifications
Occupational health examinationSeeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmfulRoutine child health examinationExamination and observation for other reasons
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06352190
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06352190 through Pure Global AI's free database. This Phase 1 trial is sponsored by Shouyao Holdings (Beijing) Co. LTD and is currently Not yet recruiting. The study focuses on Healthy Subjects. Target enrollment is 8 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.