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Study of Excretion Balance and Pharmacokinetics of [14C]-SAR442168 in Healthy Male Subjects

Multiple Sclerosis Clinical Trial

Official 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

Clinical Trial Summary

Primary Objective: To determine the excretion balance and systemic exposure of radioactivity after oral administration of [14C]-SAR442168. To determine the pharmacokinetics of SAR442168 and its contribution to the overall exposure of radioactivity. To collect samples in order to determine the metabolic pathways of SAR442168 and identify the chemical structures and main excretion route of the main metabolites (samples will be analyzed according to metabolic analysis plan and results will be documented in a separate report). Secondary Objective: To assess the clinical and biological tolerability of an oral solution of SAR442168.

Clinical Trial Description

Total study duration is 3 to 10 weeks, including a screening period of 27 days, treatment period of up to 15 days and a follow-up and end of study of up to 4 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04171310
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1
Start date November 13, 2019
Completion date December 30, 2019
View Details
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