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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
Phase 1 trial testing amcenestrant in Breast Cancer in 6 participants. Completed in 19 August 2021.
19 August 2021
Quick facts
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 6 |
| Start date | 15 June 2021 |
| Primary completion | 19 August 2021 |
| Estimated completion | 19 August 2021 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- amcenestrant — full drug profile →
- [14C]-SAR439859 microtracer — full drug profile →
- [14C]-SAR439859 — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Sanofi — full company profile →
Who can join
Adults 40 to 75, female only, with Breast Cancer or Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Oral SERDs alone or in combination with CDK 4/6 inhibitors in breast cancer: Current perspectives and clinical trials.
Apostolidou K, Zografos E, Papatheodoridi MA, Fiste O, et al · · 2024 · cited 9× · PMID 38599049 · DOI 10.1016/j.breast.2024.103729 -
Optimization of small molecule degraders and antagonists for targeting estrogen receptor based on breast cancer: current status and future.
Yao J, Tao Y, Hu Z, Li J, et al · · 2023 · cited 5× · PMID 37808197 · DOI 10.3389/fphar.2023.1225951
Verify or expand the search:
- PubMed search for NCT04940026
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04940026 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sanofi
- Last refreshed: 24 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04940026.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing