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A Study in Healthy Men to Test How BI 1815368 is Processed in the Body

StatusCompleted
PhasePhase 1
Started2026-07-16
View on ClinicalTrials.gov ↗

Amendment history

2026-08-17
Study Status, Study Design, Contacts/Locations v2
Trial completed
Enrollment increased: 4 → 8 participants
Enrollment closed, study ongoing
Enrollment reduced: 10 → 4 participants
Study sitesdetails revised at 1 of 1 site
2026-07-22
Study Status, Contacts/Locations v1
Recruitment opened
Start dateestimated 2026-07-15→confirmed 2026-07-16
Study sitesdetails revised at 1 of 1 site
2026-07-03
Original filing
The main objectives are: * To assess mass balance by determining the extent of recovery of total \[¹⁴C\]-radioactivity in urine and faeces after a single oral dose administration of BI 1815368 (C-14) (test treatment T) in healthy male trial participants. * To investigate the absolute bioavailability of BI 1815368 using a single, concomitant intravenous micro-dose administration of BI 1815368 (C13) (reference treatment R). * To provide plasma, urine, and faecal samples
Trial Details
NCT Number NCT07693218
Lead Sponsor Boehringer Ingelheim
Conditions Healthy
Enrollment 8 participants
Start Date 2026-07-16
Primary Completion 2026-08-29 (estimated)
Study Completion 2026-09-04 (estimated)
Updated on ClinicalTrials.gov 2026-09-15