ADME and PK study of [14C]-SAR442168 in healthy males (QSC202211)
Research type
Research Study
Full title
An open-label study of excretion balance and pharmacokinetics following a single oral dose of [14C]-SAR442168 (Not more than 3.7 MBq) in healthy male subjects
IRAS ID
266168
Contact name
Marie-José Cabanis
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2019-001069-33
Duration of Study in the UK
0 years, 2 months, 12 days
Research summary
The Sponsor is developing the test medicine, SAR442168, for the potential treatment of Multiple Sclerosis (MS) and other autoimmune diseases.
The study will try to identify the amount of radioactivity found in the blood, urine and faeces after a single dose of radiolabelled SAR442168 ([14C]-SAR442168). "Radiolabelled’ means that the test medicine has a radioactive component (14C) which helps us to track where and how much of the test medicine is distributed i.e. in the blood, urine and faeces. The study will also look at how SAR442168 is taken up by the body and how SAR442168 is broken down by the body by testing for the breakdown products (metabolites) and looking at their structure(s).
The study will consist of a single study period involving 6 healthy male volunteers. Each volunteer will receive a single oral dose of radiolabelled SAR442168 as a solution to drink. Blood, urine and faecal samples will then be collected at regular intervals from each volunteer who will be resident in the clinical unit from 8 to up to a maximum of 15 days. Volunteers may be required to return weekly for a maximum of 4 additional visits if necessary and each volunteer will attend a follow up visit 7 to 10 days after their last collection or on their final return visit, which ever is sooner.
REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/1528
Date of REC Opinion
15 Oct 2019
REC opinion
Favourable Opinion