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A Study to Evaluate the Mass Balance of [14C] SY-5007 in Healthy Adult Male Subjects in China - Trial NCT06352190

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.

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NCT06352190
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06352190
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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

Study Focus

Healthy Subjects

[14C] SY-5007

Interventional

drug

Sponsor & Location

Shouyao Holdings (Beijing) Co. LTD

Beijing, China

Timeline & Enrollment

Phase 1

May 01, 2024

Jun 01, 2024

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: tยฝ,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 examination
Seeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmful
Routine child health examination
Examination and observation for other reasons

Data Source

ClinicalTrials.gov

NCT06352190

Non-Device Trial