Clinical Trials Directory

Trials / Completed

CompletedNCT03654170

A Study in Healthy Men to Find Out How BI 425809 is Taken up and Handled by the Body

Metabolism and Pharmacokinetics of BI 425809 After Administration of BI 425809 (C-14) as Oral Solution in Healthy Male Volunteers

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

This trial intends to investigate the basic pharmacokinetics of BI 425809 and \[14C\]- radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of 25 mg BI 425809 (C-14) given to healthy male subjects

Conditions

Interventions

TypeNameDescription
DRUGBI 425809 mixed with [C-14] BI425809Single oral dose of 25 milligram (mg) mixture of Carbon 14 labelled \[14C\] BI 425809 XX, containing a radioactive dose of 3.7 MegaBecquerel (MBq), and unlabeled BI 425809 XX dissolved in 12.5 milliliter (mL) polyethylene glycol 400 (PEG) as solvent.

Timeline

Start date
2018-09-11
Primary completion
2018-11-12
Completion
2018-11-12
First posted
2018-08-31
Last updated
2026-03-27
Results posted
2026-03-27

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT03654170. Inclusion in this directory is not an endorsement.