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

Sanofi6 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Sclerosis

Interventions

Eligibility

Sex: MALEMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Percentage of radioactive dose excreted in urine and feces

Fractional and cumulative percentage of radioactive dose excreted in urine and feces of \[14C\]-SAR442168

Time frame: Day 1 to Day 43

Secondary Outcomes

Number of subjects with Adverse events

Adverse events, spontaneously reported by the subject or observed by the Investigator

Time frame: From Day -1 to 43

Blood/plasma radioactivity ratio

Blood/plasma radioactivity ratio for Cmax

Time frame: Day 1 up to Day 43

Blood/plasma radioactivity ratio

Blood/plasma radioactivity ratio for AUC

Time frame: Day 1 up to Day 43

Plasma SAR442168 /radioactivity ratio

Plasma SAR442168 /radioactivity ratio for Cmax

Time frame: Day 1 up to Day 43

Plasma SAR442168 /radioactivity ratio

Plasma SAR442168 /radioactivity ratio for AUC

Time frame: Day 1 up to Day 43

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes