A Phase 1 interventional study of amcenestrant and [14C]-SAR439859 microtracer in Breast Cancer and Healthy Volunteers, sponsored by Sanofi. Completed at 1 site in United Kingdom. Open to female participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by Sanofi · Phase 1, Interventional, and Other
Primary Objectives:
Secondary objectives:
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 6 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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).
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.
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
Drug: amcenestrant · Drug: [14C]-SAR439859 microtracer · Drug: [14C]-SAR439859
Tablet Oral
Also known as: SAR439859
Solution for infusion Intravenous
Powder for oral solution Oral
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
Area under the plasma concentration versus time curve extrapolated to infinity
Time frame: 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)
Time frame: Day 1 to Day 3
Assessment of PK parameter: CL for SAR439859 after IV administration
Total body clearance
Time frame: Day 1 to Day 3
Assessment of PK parameter: AUC ratios after IV administration
SAR439859 to radioactivity ratio for plasma AUC
Time frame: Day 1 to Day 3
Assessment of PK parameter: Cmax for radioactivity and SAR439859 after oral administration
Maximum plasm concentration observed
Time frame: 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
Time frame: Day 1 to Day 5, Day 7 to Day 11
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
SAR439859 to radioactivity ratio for plasma AUC
Time frame: Day 7 to Day 11
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
M7 to SAR439859 ratio for plasma Cmax
Time frame: 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
Time frame: 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
Time frame: Day 1 to Day 5, Day 7 to Day 11
Relative bioavailability of SAR439859 after oral administration
Time frame: Day 1 to Day 5, Day 7 to Day 11
Number of participants with adverse events
Time frame: Day 1 to Day 44
Plan to share: 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
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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