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A Study in Healthy Men to Test How BI 1291583 is Processed in the Body

NCT05833035 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-01-21

Study results available
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Summary

The main objective of this trial is to

* Assess the mass balance and total recovery of \[14C\]-radioactivity in urine and faeces following a dose of BI 1291583 (C-14)
* Provide plasma and urine samples for pharmacokinetic investigations
* Provide plasma, urine, and faeces samples for metabolic profiling and structural identification of metabolites

Conditions

  • Healthy

Interventions

DRUG

BI 1291583 mixed with [C-14] BI 1291583

BI 1291583 mixed with radioactive carbon labelled \[C-14\] BI 1291583

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
2023-04-24
Primary Completion
2023-07-05
Completion
2023-07-05

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 NCT05833035 on ClinicalTrials.gov