NCT05238714

Excretion Balance, Pharmacokinetics, and Metabolism Following of [14C]-Venglustat Administration in Healthy Male Subjects

An Open-label Study of Excretion Balance and Pharmacokinetics Following a Single Oral Dose of [14C]-Venglustat (2.67 MBq) in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Primary Objectives: * To determine the excretion balance and systemic exposure of radioactivity after oral administration of \[14C\]-venglustat. * To determine the pharmacokinetics (PK) of venglustat and its contribution to the overall exposure of radioactivity. * To determine the metabolic pathways, metabolite profile, chemical structures and main excretion route of the main venglustat metabolites and the metabolite contribution to the overall exposure of radioactivity. Secondary Objective: To assess the clinical and biological tolerability of oral solution of venglustat

Detailed description

43 days

Conditions

• Disorders of Sphingolipid Metabolism
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	venglustat	Powder for Oral solution

Timeline

• Start date: 2020-05-26
• Primary completion: 2020-06-26
• Completion: 2020-06-26
• First posted: 2022-02-14
• Last updated: 2025-09-17

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study