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

NCT05238714 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-09-17

No results posted yet for this study

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

Conditions

  • Disorders of Sphingolipid Metabolism
  • Healthy Volunteers

Interventions

DRUG

venglustat

Powder for Oral solution

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-26
Primary Completion
2020-06-26
Completion
2020-06-26
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05238714 on ClinicalTrials.gov