At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-micro-tracer Human Absorption, Distribution, Metabolism and Excretion (hADME) and Absolute Bioavailability Trial After a Single Oral Dose of BI 1569912 (C-14) and a Single, Concomitant, Intravenous Micro-dose of BI 1569912 (C-13) in Healthy Male Subjects (a Phase I, Open-label, Non-randomised, Single-dose, Fixed-sequence Trial)
In Brief
A Phase 1 clinical trial evaluating BI 1569912 (C-14) and BI 1569912 (C-13) for Healthy. Completed, enrolled 8 participants across 1 site.
Detailed Summary
The main objectives of this trial are: * To investigate basic pharmacokinetics of BI 1569912 and total radioactivity, including mass balance, excretion pathways and metabolism following oral administration of BI 1569912 (C-14) to healthy male subjects (test treatment, T). * To investigate the absolute bioavailability of BI 1569912 as single oral solution dose, using a single, concomitant intravenous micro-tracer administration of BI 1569912 (C-13) (reference treatment, R)
Study Details
Timeline
Interventions
10 milligram (mg) \[14C\]-labeled BI 1569912 mixed with unlabeled BI 1569912 taken as an oral solution.
A single dose of 100 microgram (µg) \[13C\]-labeled BI 1569912 taken as an intravenous (i.v.) infusion.