At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 6 enrolled
Drug / intervention
BI 425809 mixed with [C-14] BI425809drug
Likely dose
BI 425809 mixed with [C-14] BI425809 25 milligramfrom 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.
Metabolism and Pharmacokinetics of BI 425809 After Administration of BI 425809 (C-14) as Oral Solution in Healthy Male Volunteers
In Brief
A Phase 1 clinical trial evaluating BI 425809 mixed with [C-14] BI425809 for Healthy. Completed, enrolled 6 participants across 1 site.
Detailed Summary
This trial intends to investigate the basic pharmacokinetics of BI 425809 and \[14C\]- radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of 25 mg BI 425809 (C-14) given to healthy male subjects
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesNetherlands
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartSep 2018
Primary CompletionNov 2018
TodayJul 2026
First PostedAug 31, 2018
Enrollment StartSep 11, 2018
Primary CompletionNov 12, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.8 years ago
Interventions
BI 425809 mixed with [C-14] BI425809drug
Single oral dose of 25 milligram (mg) mixture of Carbon 14 labelled \[14C\] BI 425809 XX, containing a radioactive dose of 3.7 MegaBecquerel (MBq), and unlabeled BI 425809 XX dissolved in 12.5 milliliter (mL) polyethylene glycol 400 (PEG) as solvent.