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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

NCT04940026 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-09-24

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

amcenestrant

Tablet Oral

DRUG

[14C]-SAR439859 microtracer

Solution for infusion Intravenous

DRUG

[14C]-SAR439859

Powder for oral solution Oral

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-15
Primary Completion
2021-08-19
Completion
2021-08-19

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04940026 on ClinicalTrials.gov