At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 8 enrolled
Drug / intervention
BI 1291583 mixed with [C-14] BI 1291583drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating BI 1291583 mixed with [C-14] BI 1291583 for Healthy. Completed, enrolled 8 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesNetherlands
Collaborators--
Timeline
Phase 1CompletedFinished
202420252026
Enrollment StartApr 2023
First PostedApr 2023
Primary CompletionJul 2023
TodayJul 2026
First PostedApr 27, 2023
Enrollment StartApr 24, 2023
Primary CompletionJul 5, 2023
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 3.2 years ago
Interventions
BI 1291583 mixed with [C-14] BI 1291583drug
BI 1291583 mixed with radioactive carbon labelled \[C-14\] BI 1291583