drugset / Trial / NCT05238714

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

NCT05238714

Phase 1 Completed 6 enrolled Genzyme, a Sanofi Company
NaSingle-groupOpen-labelScreening

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

Timeline

Start
2020-05-26
Primary completion
2020-06-26
Completion
2020-06-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Venglustat Small molecule 2.67 mbq Oral

Indications