NCT06572111

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

A Phase I, Open-label Trial to Investigate the Metabolism, Pharmacokinetics (Following a Mass Balance Design; Part A) and Absolute Bioavailability of BI 1839100 (C-14) After Oral and Intravenous Administration (Part B) in Healthy Male Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-09-30
• Primary completion: 2024-10-28
• Completion: 2025-09-02
• First posted: 2024-08-26
• Last updated: 2025-09-23

Locations

1 site across 1 country: Netherlands