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Be Part of Research - Trial Details - Study to Determine Absorption, Metabolism, and Excretion of [14C]-SAR439859, and to Assess Absolute Oral Bioavailability of Amcenestrant (SAR439859), in Healthy Post-menopausal Women
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Study to Determine Absorption, Metabolism, and Excretion of [14C]-SAR439859, and to Assess Absolute Oral Bioavailability of Amcenestrant (SAR439859), in Healthy Post-menopausal Women

Completed

Open to: FEMALE

Age: 40.0 - 75.0

Nottingham

Medical Conditions

Breast Cancer
Healthy Volunteers

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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

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jun 2021 Aug 2021

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Tablet Oral

Intervention Arm Group : SAR439859;

Intervention Type : DRUG
Intervention Description : Solution for infusion Intravenous

Intervention Arm Group : SAR439859;

Intervention Type : DRUG
Intervention Description : Powder for oral solution Oral

Intervention Arm Group : SAR439859;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Investigational site number 8260001
    Nottingham
    NG11 6JS


The study is sponsored by Sanofi




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Read full details for Trial ID: NCT04940026
Last updated 19 September 2025

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