NCT05833035

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

A Phase I, Open-label, Single Dose, Mass Balance Trial to Investigate Metabolism and Pharmacokinetics of BI 1291583 (C-14) Administered as Oral Solution in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	BI 1291583 mixed with [C-14] BI 1291583	BI 1291583 mixed with radioactive carbon labelled \[C-14\] BI 1291583

Timeline

• Start date: 2023-04-24
• Primary completion: 2023-07-05
• Completion: 2023-07-05
• First posted: 2023-04-27
• Last updated: 2026-01-21
• Results posted: 2026-01-21

Locations

1 site across 1 country: Netherlands