NCT04771286

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 1015550 (C-14)	BI 1015550 (C-14)

Timeline

• Start date: 2021-03-25
• Primary completion: 2021-05-17
• Completion: 2021-05-17
• First posted: 2021-02-25
• Last updated: 2025-11-28
• Results posted: 2025-11-28

Locations

1 site across 1 country: Netherlands