Astrazeneca - A Phase 1 Study to Evaluate Absolute Bioavailability and Absorption, Distribution, Metabolism and Excretion of Savolitinib in Healthy Male Volunteers

Quotient Sciences and AstraZeneca co-authored a peer-reviewed study published in Clinical Pharmacology in Drug Development.

The study details a Phase 1 clinical trial evaluating the absolute bioavailability and ADME of Savolitinib, an oral MET tyrosine kinase inhibitor. Conducted in healthy male volunteers, the study used a radiolabeled micro-tracer approach to assess pharmacokinetics. 

Results showed rapid absorption (Tmax ~2–4 hours), a short half-life (~4–7 hours), and no drug accumulation with once- or twice-daily dosing. 

The study also characterized two metabolites: M2 (N-desmethyl savolitinib) and M3 (hydroxy savolitinib), with 33% and 12% exposure relative to the parent compound, respectively.

Download the paper to read additional details about the early clinical program.