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

Study Overview
=================
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.

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

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: SAR442168


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Healthy male subjects 30 to 65 years of age. Body Mass Index 18 up to 32 kg/m2, inclusive. Signed informed consent. Subjects must agree to the use of an adequate method of contraception for up to 3 months after discharge from the clinical unit Exclusion criteria: Radiation exposure exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last five years (including diagnostic X-rays and other medical exposures). Occupationally exposure to radiation (as defined in the Ionizing Radiations Regulations 2017). Irregular bowel habits (more than 3 bowel movements/day or less than 1 every 2 days) . Social habits: smoking, alcohol abuse, drug abuse etc. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAR442168<br>Single oral dose of SAR442168 (as a nonsalified compound) containing (NMT) 3.7 MBq of [14C]-SAR442168 | Drug: SAR442168<br>* Pharmaceutical form:oral solution Route of administration: Oral<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of radioactive dose excreted in urine and feces | Fractional and cumulative percentage of radioactive dose excreted in urine and feces of [14C]-SAR442168 | Day 1 to Day 43 | 

Secondary Outcome Measures

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