A Study of Carbon-14-Labelled [14C] LOXO-305 (Pirtobrutinib) in Healthy Male Participants
Status:
Completed
Trial end date:
2020-11-06
Target enrollment:
Participant gender:
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.