drugset / Trial / NCT05238714
Excretion Balance, Pharmacokinetics, and Metabolism Following of [14C]-Venglustat Administration in Healthy Male Subjects
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Venglustat | Small molecule | 2.67 mbq | Oral |