Breast CancerPhase 1NCT04940026

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

A Phase 1 study testing amcenestrant, [14C]-SAR439859 microtracer and [14C]-SAR439859 in people with Breast Cancer and Healthy Volunteers, run by Sanofi at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 40 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Cancer, Healthy Volunteers
What is being tested?: amcenestrant, [14C]-SAR439859 microtracer and [14C]-SAR439859
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited Kingdom
Study dates: 15 Jun 2021to 19 Aug 2021
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 75 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Female participants (age between 40 and 75 years old) who are postmenopausal or had post-bilateral surgical oophorectomy not linked to a history of cancer.
Participants who are overtly healthy. Body weight within 40.0 and 95.0 kg and body mass index (BMI) within the range 18.0 and 30 kg/m2 (inclusive).
Capable of giving signed informed consent.

Who cannot join

Subject has clinical signs and symptoms consistent with COVID-19, e.g., fever, dry cough, dyspnea, loss of taste and smell, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening.
Subject who had severe course of COVID-19 (i.e., hospitalization, extracorporeal membrane oxygenation, mechanically ventilated).
Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
Blood donation, any volume (usually approximately 500 mL), within 2 months before inclusion.
Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day).

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Smoking regularly more than 5 cigarettes or equivalent per week, unable to stop smoking during the study (occasional smoker can be enrolled).
Excessive consumption of beverages containing xanthine bases (more than 5 cups or glasses per day).
Subjects who are occupationally exposed to radiation as defined in the Ionizing Radiation Regulations 2017.
Participation in a trial with [13C] or [14C] radiolabeled medication in the 12 months preceding the study.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Investigational Site Number 8260001
Nottingham, NG11 6JS

Other trials in United Kingdom

About this study

Official title: A Phase 1, Open-label, Single Center, One Period, One Sequence Study to Determine Absorption, Metabolism, and Excretion of a Single Oral Dose of Radiolabeled [14C]- SAR439859 and an Assessment of the Absolute Oral Bioavailability Using the Microdosing Technique in Healthy Post-menopausal Women

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

Read the detailed description

Total study duration is 3 to 10 weeks, including a screening period of up to 27 days, treatment period of up to 16 days and a follow-up and end of study of up to 4 weeks.

Conditions: Breast Cancer, Healthy Volunteers
Being tested: amcenestrant, [14C]-SAR439859 microtracer, [14C]-SAR439859
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

amcenestrantDrug
Also called SAR439859
Tablet Oral
[14C]-SAR439859 microtracerDrug
Solution for infusion Intravenous
[14C]-SAR439859Drug
Powder for oral solution Oral

Study groups in NCT04940026
Study group	Role	What they receive
SAR439859	Experimental	Single oral dose of SAR439859 at Day 1 in fasted condition followed by intravenous administration of [14C]-SAR439859 microtracer 3 hours later, and single oral dose of [14C]-SAR439859 at Day 7 in fasted condition Receives: Drug: amcenestrant; Drug: [14C]-SAR439859 microtracer; Drug: [14C]-SAR439859

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of radioactive dose, SAR439859 and M7 excreted in urine and feces after IV administration
Measured: Day 1 to Day 6
Percentage of radioactive dose excreted in urine and feces after oral administration
Measured: Day 7 up to max Day 44
Assessment of Pharmacokinetic (PK) parameter: AUC for radioactivity and SAR439859 after IV administration
Area under the plasma concentration versus time curve extrapolated to infinity
Measured: Day 1 to Day 3
Assessment of PK parameter: t1/2z for radioactivity and SAR439859 after IV administration
Terminal half-life associated with the terminal slope (λz)
Measured: Day 1 to Day 3
Assessment of PK parameter: CL for SAR439859 after IV administration
Total body clearance
Measured: Day 1 to Day 3
Assessment of PK parameter: AUC ratios after IV administration
SAR439859 to radioactivity ratio for plasma AUC
Measured: Day 1 to Day 3
Assessment of PK parameter: Cmax for radioactivity and SAR439859 after oral administration
Maximum plasm concentration observed
Measured: Day 1 to Day 5, Day 7 to Day 11
Assessment of PK parameter: tmax for radioactivity and SAR439859 after oral administration
Time to reach Cmax
Measured: Day 1 to Day 5, Day 7 to Day 11
Assessment of PK parameter: AUC for radioactivity and SAR439859 after oral administration
Measured: Day 1 to Day 5, Day 7 to Day 11
Assessment of PK parameter: t1/2z for radioactivity and SAR439859 after oral administration
Measured: Day 1 to Day 5, Day 7 to Day 11
Assessment of PK parameter: AUC ratios after oral administration
SAR439859 to radioactivity ratio for plasma AUC
Measured: Day 7 to Day 11
Assessment of PK parameter: Cmax for M7 after IV and oral administration
Measured: Day 1 to Day 5, Day 7 to Day 11
Assessment of PK parameter: AUC for M7 after IV and oral administration
Measured: Day 1 to Day 5, Day 7 to Day 11
Assessment of PK parameter: t1/2z for M7 after IV and oral administration
Measured: Day 1 to Day 5, Day 7 to Day 11
Assessment of PK parameter: Rmet Cmax after IV and oral administration
M7 to SAR439859 ratio for plasma Cmax
Measured: Day 1 to Day 5, Day 7 to Day 11
Assessment of PK parameter: Rmet AUC after IV and oral administration
M7 to SAR439859 ratio for plasma AUC
Measured: Day 1 to Day 5, Day 7 to Day 11
Absolute oral bioavailability of SAR439859
Absolute oral bioavailability, expressed as a percentage, estimated from AUCs obtained after oral and IV administration
Measured: Day 1 to Day 5, Day 7 to Day 11
Relative bioavailability of SAR439859 after oral administration
Measured: Day 1 to Day 5, Day 7 to Day 11

Secondary outcomes (1)

Number of participants with adverse events
Measured: Day 1 to Day 44

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 202119 Aug 2021

First posted25 Jun 2021
Study start15 Jun 2021
Primary completion19 Aug 2021
Study completion19 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by SanofiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04940026
Sponsor's protocol ID: BEX15859
Status last verified: Sep 2025
First submitted: 14 Jun 2021
Last updated: 24 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Single Center, One Period, One Sequence Study to Determine Absorption, Metabolism, and Excretion of a Single Oral Dose of Radiolabeled [14C]- SAR439859 and an Assessment of the Absolute Oral Bioavailability Using the Microdosing Technique in Healthy Post-menopausal Women
ClinicalTrials.gov ID: NCT04940026
Acronym / sponsor ID: BEX15859
Conditions: Breast Cancer, Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: 15 Jun 2021 (actual)
Primary completion: 19 Aug 2021 (actual)
Study completion: 19 Aug 2021 (actual)
First posted: 25 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Total study duration is 3 to 10 weeks, including a screening period of up to 27 days, treatment period of up to 16 days and a follow-up and end of study of up to 4 weeks.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SAR439859	Experimental	Drug: amcenestrant, Drug: [14C]-SAR439859 microtracer, Drug: [14C]-SAR439859Single oral dose of SAR439859 at Day 1 in fasted condition followed by intravenous administration of [14C]-SAR439859 microtracer 3 hours later, and single oral dose of [14C]-SAR439859 at Day 7 in fasted condition

Who may qualify

Ages: 40 to 75 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Female participants (age between 40 and 75 years old) who are postmenopausal or had post-bilateral surgical oophorectomy not linked to a history of cancer.
Participants who are overtly healthy. Body weight within 40.0 and 95.0 kg and body mass index (BMI) within the range 18.0 and 30 kg/m2 (inclusive).
Capable of giving signed informed consent.

Key exclusion criteria (11 listed)

Subject has clinical signs and symptoms consistent with COVID-19, e.g., fever, dry cough, dyspnea, loss of taste and smell, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening.
Subject who had severe course of COVID-19 (i.e., hospitalization, extracorporeal membrane oxygenation, mechanically ventilated).
Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
Blood donation, any volume (usually approximately 500 mL), within 2 months before inclusion.
Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
amcenestrantAlso: SAR439859Tablet Oral	Drug	SAR439859
[14C]-SAR439859 microtracerSolution for infusion Intravenous	Drug	SAR439859
[14C]-SAR439859Powder for oral solution Oral	Drug	SAR439859

Primary outcome

Percentage of radioactive dose, SAR439859 and M7 excreted in urine and feces after IV administration
Time frame: Day 1 to Day 6
Percentage of radioactive dose excreted in urine and feces after oral administration
Time frame: Day 7 up to max Day 44
Assessment of Pharmacokinetic (PK) parameter: AUC for radioactivity and SAR439859 after IV administration
Time frame: Day 1 to Day 3
Area under the plasma concentration versus time curve extrapolated to infinity
Assessment of PK parameter: t1/2z for radioactivity and SAR439859 after IV administration
Time frame: Day 1 to Day 3
Terminal half-life associated with the terminal slope (λz)
Assessment of PK parameter: CL for SAR439859 after IV administration
Time frame: Day 1 to Day 3
Total body clearance
Assessment of PK parameter: AUC ratios after IV administration
Time frame: Day 1 to Day 3
SAR439859 to radioactivity ratio for plasma AUC
Assessment of PK parameter: Cmax for radioactivity and SAR439859 after oral administration
Time frame: Day 1 to Day 5, Day 7 to Day 11
Maximum plasm concentration observed
Assessment of PK parameter: tmax for radioactivity and SAR439859 after oral administration
Time frame: Day 1 to Day 5, Day 7 to Day 11
Time to reach Cmax
Assessment of PK parameter: AUC for radioactivity and SAR439859 after oral administration
Time frame: Day 1 to Day 5, Day 7 to Day 11
Assessment of PK parameter: t1/2z for radioactivity and SAR439859 after oral administration
Time frame: Day 1 to Day 5, Day 7 to Day 11
Assessment of PK parameter: AUC ratios after oral administration
Time frame: Day 7 to Day 11
SAR439859 to radioactivity ratio for plasma AUC
Assessment of PK parameter: Cmax for M7 after IV and oral administration
Time frame: Day 1 to Day 5, Day 7 to Day 11
Assessment of PK parameter: AUC for M7 after IV and oral administration
Time frame: Day 1 to Day 5, Day 7 to Day 11
Assessment of PK parameter: t1/2z for M7 after IV and oral administration
Time frame: Day 1 to Day 5, Day 7 to Day 11
Assessment of PK parameter: Rmet Cmax after IV and oral administration
Time frame: Day 1 to Day 5, Day 7 to Day 11
M7 to SAR439859 ratio for plasma Cmax
Assessment of PK parameter: Rmet AUC after IV and oral administration
Time frame: Day 1 to Day 5, Day 7 to Day 11
M7 to SAR439859 ratio for plasma AUC
Absolute oral bioavailability of SAR439859
Time frame: Day 1 to Day 5, Day 7 to Day 11
Absolute oral bioavailability, expressed as a percentage, estimated from AUCs obtained after oral and IV administration
Relative bioavailability of SAR439859 after oral administration
Time frame: Day 1 to Day 5, Day 7 to Day 11

1 secondary outcome

Number of participants with adverse events
Time frame: Day 1 to Day 44

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
BEX15859 Plain Language Results SummaryLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing amcenestrant, [14C]-SAR439859 microtracer and [14C]-SAR439859 in people with Breast Cancer and Healthy Volunteers, run by Sanofi at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of radioactive dose, SAR439859 and M7 excreted in urine and feces after IV administration (time frame: Day 1 to Day 6). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04940026.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.