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A Study in Healthy Men to Measure the Amount of BI 425809 in the Blood When Taken as a Tablet

NCT03783000 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-03-27

Study results available
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Summary

The primary objective of this trial is to investigate the absolute oral bioavailability of BI 425809 administered as tablet (Test, T) compared to \[C-14\]-BI 425809 administered as intravenous microtracer (Reference, R).

Conditions

  • Healthy

Interventions

DRUG

BI 425809

One 25 mg film coated tablet administered with 240 milliliters of water after an overnight fast of at least 10 hours.

DRUG

[C-14]-BI 425809

Intravenous micro-tracer infusion of 30 μg BI 425809 (14-C) administered 4 hours after treatment T.

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
2019-01-15
Primary Completion
2019-03-06
Completion
2019-03-06

Countries

  • Netherlands

Study Locations

More Related Trials

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 NCT03783000 on ClinicalTrials.gov