Multiple Sclerosis
Conditions
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.
Interventions
DRUGSAR442168
Pharmaceutical form:oral solution Route of administration: Oral
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 Cmax |
| Plasma SAR442168 /radioactivity ratio | Day 1 up to Day 43 | Plasma SAR442168 /radioactivity ratio for Cmax |
Countries
United Kingdom
Outcome results
None listed