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drugset / Trial / NCT04771286

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

NCT04771286 ↗

Phase 1 Completed 6 enrolled Boehringer Ingelheim
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2021-03-25
Primary completion
2021-05-17
Completion
2021-05-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Nerandomilast Small molecule 18 mg Oral

Indications

No indication recorded.