Primary Objectives: * To assess the excretion balance after oral and IV administration of \[14C\]-SAR439859 * To assess PK of total radioactivity, \[14C\] -SAR439859 and its metabolite (M7) after IV administration of \[14C\]-SAR439859 and, PK of radioactivity, SAR439859 and M7 after oral administration of SAR439859 alone or with \[14C\]-SAR439859 * To assess IV clearance and absolute bioavailability of SAR439859 using microdose of \[14C\]-SAR439859 tracer on top of a single tablet oral dose. * To assess relative bioavailability of SAR439859 given as tablet or solution Secondary objectives: * To collect samples in order to assess metabolic profile in plasma and excreta of SAR439859 after oral administration of \[14C\]-SAR439859 as solution, contribution in plasma of SAR439859 and metabolite relative to total radioactivity and identify metabolites (samples will be analyzed according to metabolic analysis plan and results will be documented in a separate report). * To assess safety and tolerance of SAR439859
Age range
40 Years – 75 Years
Sex
FEMALE
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Percentage of radioactive dose, SAR439859 and M7 excreted in urine and feces after IV administration
Timeframe: Day 1 to Day 6
Percentage of radioactive dose excreted in urine and feces after oral administration
Timeframe: Day 7 up to max Day 44
Assessment of Pharmacokinetic (PK) parameter: AUC for radioactivity and SAR439859 after IV administration
Timeframe: Day 1 to Day 3
Assessment of PK parameter: t1/2z for radioactivity and SAR439859 after IV administration
Timeframe: Day 1 to Day 3
Assessment of PK parameter: CL for SAR439859 after IV administration
Timeframe: Day 1 to Day 3
Assessment of PK parameter: AUC ratios after IV administration
Timeframe: Day 1 to Day 3
Assessment of PK parameter: Cmax for radioactivity and SAR439859 after oral administration
Timeframe: Day 1 to Day 5, Day 7 to Day 11
Assessment of PK parameter: tmax for radioactivity and SAR439859 after oral administration
Timeframe: Day 1 to Day 5, Day 7 to Day 11
Assessment of PK parameter: AUC for radioactivity and SAR439859 after oral administration
Timeframe: Day 1 to Day 5, Day 7 to Day 11
Assessment of PK parameter: t1/2z for radioactivity and SAR439859 after oral administration
Timeframe: Day 1 to Day 5, Day 7 to Day 11
Assessment of PK parameter: AUC ratios after oral administration
Timeframe: Day 7 to Day 11
Assessment of PK parameter: Cmax for M7 after IV and oral administration
Timeframe: Day 1 to Day 5, Day 7 to Day 11
Assessment of PK parameter: AUC for M7 after IV and oral administration
Timeframe: Day 1 to Day 5, Day 7 to Day 11
Assessment of PK parameter: t1/2z for M7 after IV and oral administration
Timeframe: Day 1 to Day 5, Day 7 to Day 11
Assessment of PK parameter: Rmet Cmax after IV and oral administration
Timeframe: Day 1 to Day 5, Day 7 to Day 11
Assessment of PK parameter: Rmet AUC after IV and oral administration
Timeframe: Day 1 to Day 5, Day 7 to Day 11
Absolute oral bioavailability of SAR439859
Timeframe: Day 1 to Day 5, Day 7 to Day 11
Relative bioavailability of SAR439859 after oral administration
Timeframe: Day 1 to Day 5, Day 7 to Day 11