At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 13 enrolled
Drug / intervention
Midazolam +4 moredrug
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 Study to Investigate the Effects of Multiple Doses of BI 425809 on the Single Dose Pharmacokinetics of Cytochrome P450 Substrates (Midazolam, Warfarin and Omeprazole) and a P Glycoprotein Substrate (Digoxin) Administered Orally in an Open-label, One-sequence Trial in Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating Midazolam, Warfarin, and 3 other interventions for Healthy. Completed, enrolled 13 participants across 1 site.
Detailed Summary
To assess the influence of multiple doses of BI 425809 on single dose pharmacokinetics of midazolam (CYP3A4 probe drug), warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug) and digoxin (P-gp probe drug)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartSep 2015
Primary CompletionOct 2015
First PostedMay 2016
TodayJul 2026
First PostedMay 26, 2016
Enrollment StartSep 7, 2015
Primary CompletionOct 30, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.1 years ago
Interventions
Midazolamdrug
Warfarindrug
Omeprazoledrug
Digoxindrug
BI 425809drug
Tablet