Excretion Balance and PK of [14C]-Venglustat in Males (QSC200939)
Research type
Research Study
Full title
An open-label study of excretion balance and pharmacokinetics following a single oral dose of [14C]-venglustat (2.67 MBq) in healthy male subjects
IRAS ID
261143
Contact name
Rand Sutherland
Contact email
Sponsor organisation
Genzyme Corporation
Eudract number
2019-001041-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 16 days
Research summary
The Sponsor are developing the test medicine, venglustat (GZ402671), to treat a rare group of diseases that affect the way certain types of fats are broken down by the body. In this group of diseases certain fats cannot be broken down by the body’s cells and they abnormally build up inside the cells causing damage. Depending upon the cells and organs affected, patients may have kidney failure, Parkinson’s disease, heart attacks or strokes at an early age.
This study involves radiolabelling (labelling the test medicine with radioactive 14C) which is used to locate the test medicine within the body. The study aims to identify the level of test medicine in the body, how quickly and into what other substances (metabolites) it’s broken down into and how it is removed from the body.
Blood, urine and faecal samples will be collected from volunteers, allowing identification and profiling of metabolites from venglustat to learn the structure and properties of these. The amount of venglustat found in each sample will also be assessed.
The study will administer the test medicine to 6 male volunteers. Volunteers will receive one dose of the test medicine as a solution to drink on Day 1. Volunteers will remain in clinic until at least Day 8 and will be discharged once the discharge criteria for radioactivity recovery have been met. If this isn't reached by Day 8 the stay will be extended up to Day 15. If the discharge criteria are not met on Day 15, volunteers will be discharged to return to the clinical unit once weekly (no overnight stay) for a maximum of 4 additional weeks. Volunteers will then have a follow up visit 7 to 10 days after their last sample collection or on the last return visit (up to Day 43), whichever is earliest.
REC name
Wales REC 2
REC reference
20/WA/0069
Date of REC Opinion
13 Mar 2020
REC opinion
Favourable Opinion