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A Study in Healthy Men to Find Out How BI 1015550 is Taken up and Handled by the Body

Healthy Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04771286
Study type Interventional
Source Boehringer Ingelheim
Contact
Status Completed
Phase Phase 1
Start date March 25, 2021
Completion date May 17, 2021
View Details
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