Open-Label Study Assessing Relative and Absolute Bioavailability of Oral Camizestrant Formulations and Food Effects in Healthy Postmenopausal Women.

ABSTRACT: Camizestrant is the next-generation oral selective estrogen receptor degrader and complete estrogen receptor antagonist in Phase 3 development for hormone receptor-positive breast cancer. To investigate the impact of manufacturing changes during pivotal Phase 3 studies, this open-label, randomized crossover study of 32 postmenopausal healthy volunteers determined the relative bioavailability of a tablet used in early clinical studies (Phase 1 tablet), a tablet designed for late-phase development (prototype Phase 3 tablet), and an oral solution. Absolute oral bioavailability in the fasted state (using a [¹⁴C] camizestrant intravenous microtracer) and effects of a high-fat meal on the prototype Phase 3 tablet were also determined. The geometric mean ratios (GMRs) of the prototype

SUBMITTER: Sykes A 

PROVIDER: S-EPMC12820339 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature