NCT04171310

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Sanofi · Industry
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	SAR442168	Pharmaceutical form:oral solution Route of administration: Oral

Timeline

• Start date: 2019-11-13
• Primary completion: 2019-12-30
• Completion: 2019-12-30
• First posted: 2019-11-20
• Last updated: 2025-09-23

Locations

1 site across 1 country: United Kingdom