Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04940026 | Study to Determine Absorption, Metabolism, and Excretion of [14C]-SAR439859, and to Assess Absolute Oral Bioavailability of Amcenestrant (SAR439859), in Healthy Post-menopausal Women | PHASE1 | COMPLETED | 6 | — | — | Jun 15, 2021 | Aug 19, 2021 | Sep 24, 2025 | 1 | United Kingdom |
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 ...