Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
amcenestrant · 1 trial · 2 indications
Area under the plasma concentration versus time curve extrapolated to infinity
Terminal half-life associated with the terminal slope (λz)
Total body clearance
SAR439859 to radioactivity ratio for plasma AUC
Maximum plasm concentration observed
Time to reach Cmax
SAR439859 to radioactivity ratio for plasma AUC
M7 to SAR439859 ratio for plasma Cmax
M7 to SAR439859 ratio for plasma AUC
Absolute oral bioavailability, expressed as a percentage, estimated from AUCs obtained after oral and IV administration
| Arm | Type | Description |
|---|---|---|
| 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 |
| Name | Type | Description |
|---|---|---|
| amcenestrant | DRUG | Tablet Oral |
| [14C]-SAR439859 microtracer | DRUG | Solution for infusion Intravenous |
| [14C]-SAR439859 | DRUG | Powder for oral solution Oral |
Inclusion Criteria: 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 ...
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Amcenestrant is an investigational small molecule being studied for the treatment of breast cancer. It is currently in Phase 1 clinical development. The drug is being evaluated in healthy post-menopausal women as part of a study to understand its absorption, metabolism, and excretion.
Amcenestrant is being developed by Sanofi, a global biopharmaceutical company. Sanofi's stock is traded under the ticker symbol SNY. The drug is currently in Phase 1 clinical development for breast cancer.
Amcenestrant is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 study has been completed, which involved 6 participants.
Amcenestrant has one completed clinical trial, registered as NCT04940026. This Phase 1 study was designed to determine the absorption, metabolism, and excretion of the drug and to assess its absolute oral bioavailability in healthy post-menopausal women. The study was conducted in the United Kingdom.
Yes, amcenestrant is also known as SAR439859. The clinical trial NCT04940026 refers to the drug as SAR439859. This alternative name is used in the study title and is important for identifying the drug in clinical trial registries.