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

NCT04771286 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-11-28

Study results available
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Summary

The main objective of this trial is to investigate the basic pharmacokinetics of BI 1015550 and its metabolite BI 764333 (M480), \[14C\]-radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose BI 1015550 (C-14) administered to healthy male subjects.

The primary objective is:

\- To assess the mass balance recovery of \[14C\]-radioactivity from urine and faeces as well as vomit in case of occurrence after a single oral dose of BI 1015550 (C-14) administered to healthy male subjects

The secondary objectives are:

* To assess the pharmacokinetics of \[C-14\]-BI 1015550 and BI 1015550 as well as its metabolite BI 764333 in plasma following a single oral dose of BI 1015550 (C-14)
* To assess the safety and tolerability of BI 1015550

Conditions

  • Healthy

Interventions

DRUG

BI 1015550 (C-14)

BI 1015550 (C-14)

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
2021-03-25
Primary Completion
2021-05-17
Completion
2021-05-17

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 NCT04771286 on ClinicalTrials.gov