A Human Mass Balance and Metabolism Study of [¹⁴C]-Ubrogepant in Healthy Male Adults.

ABSTRACT: Ubrogepant is a calcitonin gene-related peptide receptor antagonist approved for the acute treatment of migraine with or without aura in adults. The mass balance and metabolism of ubrogepant was evaluated in six healthy male adults administered a single oral dose of [¹⁴C]-ubrogepant 50 mg (∼200 µCi). Overall, the mean total radioactivity recovery was 92.4% (95% CI: 77.8%-107%) of the administered dose, with 82.9% in feces (95% CI: 66.7%-99.1%) and 9.52% in urine (95% CI: 7.78%-11.3%). Ubrogepant was eliminated mainly via metabolism, primarily via biliary/fecal excretion. Approximately 42% and 6% of the dose was excreted as unchanged parent drug in feces and urine, respectively. The major circulating components of drug-related material (DRM) in pooled plasma samples were ubrogepa

SUBMITTER: Boinpally RR 

PROVIDER: S-EPMC12821552 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature