drugset / Trial / NCT04171310

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

NCT04171310

Phase 1 Completed 6 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2019-11-13
Primary completion
2019-12-30
Completion
2019-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Tolebrutinib Small molecule 3.7 mbq Oral

Indications