At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 6 enrolled
Drug / intervention
BI 425809 +1 moredrug
Likely dose
BI 425809 25 mgfrom 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.
Investigation of Pharmacokinetics and Absolute Oral Bioavailability of BI 425809 Administered as an Oral Dose With an Intravenous Microtracer Dose of [C-14]-BI 425809 in Healthy Male Volunteers
In Brief
A Phase 1 clinical trial evaluating BI 425809 and [C-14]-BI 425809 for Healthy. Completed, enrolled 6 participants across 1 site.
Detailed Summary
The primary objective of this trial is to investigate the absolute oral bioavailability of BI 425809 administered as tablet (Test, T) compared to \[C-14\]-BI 425809 administered as intravenous microtracer (Reference, R).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesNetherlands
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartJan 2019
Primary CompletionMar 2019
TodayJul 2026
First PostedDec 20, 2018
Enrollment StartJan 15, 2019
Primary CompletionMar 6, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.5 years ago
Interventions
BI 425809drug
One 25 mg film coated tablet administered with 240 milliliters of water after an overnight fast of at least 10 hours.
[C-14]-BI 425809drug
Intravenous micro-tracer infusion of 30 μg BI 425809 (14-C) administered 4 hours after treatment T.