NCT07273474

A Study in Healthy Men and Women to Test How BI 3000202 is Taken up and Processed by the Body

A Phase I, Open-label Trial in Two Parallel Parts to Investigate Mass Balance, Metabolism, and Basic Pharmacokinetics of BI 3000202 (C-14) Administered as Oral Solution (Part A) and to Investigate Absolute Bioavailability (BA) of BI 3000202 Administered as Film Coated Tablet Together With an Intravenous Microtracer Dose of BI 3000202 (C-14) (Part B) in Healthy Male and Female Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to find out how quickly and to what extent BI 3000202 is processed in the body. The purpose of Part A is to find out how 3000202 moves through and exits the body of healthy people. The purpose of Part B is to find out how much BI 3000202 gets into the blood when participants take it as a tablet compared with when they get it as an infusion. Adults between 18 and 55 years of age can take part if the study doctor determines they are healthy. The doctors regularly check participants' health. To assess the study endpoints, the study staff takes blood, urine, and stool samples.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 3000202	BI 3000202 unlabelled
DRUG	BI 3000202 [14C]-labelled	BI 3000202 \[14C\]-labelled

Timeline

• Start date: 2025-12-30
• Primary completion: 2026-03-05
• Completion: 2026-03-25
• First posted: 2025-12-09
• Last updated: 2026-03-31

Locations

1 site across 1 country: Netherlands