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A Study in Healthy Men to Test How BI 1839100 is Taken up and Handled by the Body

NCT06572111 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-09-23

No results posted yet for this study

Summary

This trial is conducted in healthy male subjects to evaluate the drug BI 1839100. The trial has two main parts. Part A aims to understand how BI 1839100 is processed in the body after an oral dose. It measures the total recovery of the drug and its radioactive label in urine and feces. It also determines the concentrations in blood plasma and investigates the drug's metabolic pathways. Part B aims to compare the absolute bioavailability of BI 1839100 when administered orally and intravenously.

Conditions

  • Healthy

Interventions

DRUG

BI 1839100 (C-14) formulation 1

BI 1839100 (C-14) formulation 1

DRUG

BI 1839100

BI 1839100

DRUG

BI 1839100 (C-14) formulation 2

BI 1839100 (C-14) formulation 2

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2024-10-28
Completion
2025-09-02

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 NCT06572111 on ClinicalTrials.gov