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CompletedNCT05707403

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

Investigation of Pharmacokinetics and Absolute Oral Bioavailability of BI 1015550 Administered as an Oral Dose With an Intravenous Microtracer Dose of [14C]-BI 1015550 in Healthy Male Volunteers

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

Summary

This trial is intended to examine the absolute oral bioavailability of BI 1015550 as tablet formulation for oral administration, using an intravenous microtracer approach with \[14C\]-labelled BI 1015550. These data are considered necessary to further support the understanding of the pharmacokinetics of BI 1015550.

Conditions

Interventions

TypeNameDescription
DRUGBI 1015550Treatment T
DRUGBI 1015550 mixed with [C-14]-BI 1015550Treatment R

Timeline

Start date
2023-02-14
Primary completion
2023-03-28
Completion
2023-03-28
First posted
2023-01-31
Last updated
2025-11-28
Results posted
2025-11-28

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT05707403. Inclusion in this directory is not an endorsement.

A Study in Healthy Men to Test How BI 1015550 is Taken up and Handled by the Body (NCT05707403) · Clinical Trials Directory