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

NCT03654170 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-03-27

Study results available
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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

  • Healthy

Interventions

DRUG

BI 425809 mixed with [C-14] BI425809

Single 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.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-11
Primary Completion
2018-11-12
Completion
2018-11-12

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03654170 on ClinicalTrials.gov