At a glance
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A Phase I, Open-label, Non-randomized, Single-dose, Single-arm, Single-period Study to Investigate the Metabolism and Pharmacokinetics of [C-14]-Labelled BI 1015550 After Oral Administration in Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating BI 1015550 (C-14) for Healthy. Completed, enrolled 6 participants across 1 site.
Detailed Summary
The main objective of this trial is to investigate the basic pharmacokinetics of BI 1015550 and its metabolite BI 764333 (M480), \[14C\]-radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose BI 1015550 (C-14) administered to healthy male subjects. The primary objective is: \- To assess the mass balance recovery of \[14C\]-radioactivity from urine and faeces as well as vomit in case of occurrence after a single oral dose of BI 1015550 (C-14) administered to healthy male subjects The secondary objectives are: * To assess the pharmacokinetics of \[C-14\]-BI 1015550 and BI 1015550 as well as its metabolite BI 764333 in plasma following a single oral dose of BI 1015550 (C-14) * To assess the safety and tolerability of BI 1015550
Study Details
Timeline
Interventions
BI 1015550 (C-14)