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drugset / Trial / NCT04567316

A Study in Healthy Men to Test How BI 1358894 is Taken up and Handled by the Body

NCT04567316 ↗

Phase 1 Completed 15 enrolled Boehringer Ingelheim
Non-randomizedSequentialOpen-labelTreatment

Summary

The main objective of this trial is to investigate the basic pharmacokinetics of BI 1358894 and its metabolites, total radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of \[14C\] BI 1358894 in Part 1 and to investigate the pharmacokinetics of BI 1358894 and its metabolite(s) following multiple-dose treatment over 21 days with non- radiolabelled compound of BI 1358894 in Part 2.

Timeline

Start
2020-10-19
Primary completion
2021-01-10
Completion
2021-01-10

Drugs

EvaluationDrugModalityDoseRoute
Subject BI 1358894 Small molecule — Oral

Indications

No indication recorded.