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

Treatment tested

• Tolebrutinib

  Tyrosine-protein kinase BTK inhibitor

Other measures (3)

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.

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.