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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Shouyao Holdings (Beijing) Co. LTD · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

The trial will consist of two parts: Pilot Study: Two eligible adult male subjects will be enrolled and admitted to the clinical trial center after passing the inclusion criteria review. They will undergo training on medication administration, urine and feces collection, etc., to ensure compliance with the protocol and standard operating procedures (SOP). Subjects will fast before medication administration and provide urine and feces samples at specified intervals after dosing. Blood samples will also be collected at specified time points. Formal Study: Four to six male subjects will be enrolled, receiving a single dose of SY-5007 160 mg orally containinig roughly 120 µCi \[14C\] SY-5007. Blood, urine and feces samples will be collected at specified time points. Safety monitoring (12-lead ECG, vital signs, blood chemistry and haematology) and adverse events will be monitored throughout the study.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	[14C] SY-5007	Carbon-14 labeled SY-5007

Timeline

• Start date: 2024-05-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2024-04-08
• Last updated: 2024-04-08

Locations

1 site across 1 country: China