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

Phase 1

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: SAR442168

• Registration Number: NCT04171310
• Lead Sponsor: Sanofi

Brief 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.

Study Timeline

• Study Start: 2019-11-13
• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-20
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SAR442168	SAR442168	Single oral dose of SAR442168 (as a nonsalified compound) containing (NMT) 3.7 MBq of \[14C\]-SAR442168

Primary Outcome Measures

Name	Time	Method
Percentage of radioactive dose excreted in urine and feces	Day 1 to Day 43	Fractional and cumulative percentage of radioactive dose excreted in urine and feces of \[14C\]-SAR442168

Secondary Outcome Measures

Name	Time	Method
Number of subjects with Adverse events	From Day -1 to 43	Adverse events, spontaneously reported by the subject or observed by the Investigator
Blood/plasma radioactivity ratio	Day 1 up to Day 43	Blood/plasma radioactivity ratio for AUC
Plasma SAR442168 /radioactivity ratio	Day 1 up to Day 43	Plasma SAR442168 /radioactivity ratio for AUC

Trial Locations

Locations (1)

Investigational Site Number 8260001; 🇬🇧 Nottingham, United Kingdom