MedTrace Logo

A Study in Healthy Men to Test How BI 1569912 is Processed in the Body

NCT06520553 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-05-22

Study results available
· View outcomes & findings →

Summary

The main objectives of this trial are:

* To investigate basic pharmacokinetics of BI 1569912 and total radioactivity, including mass balance, excretion pathways and metabolism following oral administration of BI 1569912 (C-14) to healthy male subjects (test treatment, T).
* To investigate the absolute bioavailability of BI 1569912 as single oral solution dose, using a single, concomitant intravenous micro-tracer administration of BI 1569912 (C-13) (reference treatment, R)

Conditions

  • Healthy

Interventions

DRUG

BI 1569912 (C-14)

10 milligram (mg) \[14C\]-labeled BI 1569912 mixed with unlabeled BI 1569912 taken as an oral solution.

DRUG

BI 1569912 (C-13)

A single dose of 100 microgram (µg) \[13C\]-labeled BI 1569912 taken as an intravenous (i.v.) infusion.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-08-26
Primary Completion
2024-10-03
Completion
2024-10-03

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 NCT06520553 on ClinicalTrials.gov