At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I, Open-label, Two-part Study of the Absorption, Metabolism, Excretion, and the Absolute Bioavailability of [14C]-LOXO-305 in Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating [14C]-LOXO-305 and LOXO-305 for Healthy. Completed, enrolled 9 participants across 1 site.
Detailed Summary
The main purpose of this study is to evaluate the absorption, metabolism, and excretion (AME) profiles of pirtobrutinib (LOXO-305), to identify and characterize metabolites of pirtobrutinib (LOXO-305), and to assess the safety and tolerability of \[14C\] LOXO-305 in Part 1. To determine the absolute bioavailability of pirtobrutinib (LOXO-305), to evaluate the plasma concentration of total radioactivity, to evaluate the urinary excretion of \[14C\] LOXO-305 and total radioactivity, to evaluate the fecal excretion of \[14C\] LOXO-305 and total radioactivity, and to assess the safety and tolerability of pirtobrutinib (LOXO-305), and \[14C\] LOXO-305 in Part 2. Blood tests will be performed to check how much pirtobrutinib (LOXO-305) and \[14C\] LOXO-305 gets into the bloodstream and how long it takes the body to eliminate it. The study will last up to approximately 60 days for Part 1 and approximately 47 days for Part 2.
Study Details
Timeline
Interventions
Administered orally
Administered orally
Administered IV