At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 25 enrolled
Drug / intervention
BI 409306 +1 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.
Open-label, Randomised, Two-way Crossover Study to Assess the Effect of Once Daily Itraconazole on the Pharmacokinetics of BI 409306 After a Single Oral Dose in Healthy Male Volunteers Genotyped as Poor and Extensive Metabolizers of CYP2C19
In Brief
A Phase 1 clinical trial evaluating BI 409306 and Itraconazole for Healthy. Completed, enrolled 25 participants across 1 site.
Detailed Summary
The objective of the current study is to evaluate the effect of once daily itraconazole on the pharmacokinetics of BI 409306 in poor (PM) and extensive metabolisers (EM) of CYP2C19.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesSouth Korea
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 2014
Enrollment StartOct 2014
Primary CompletionJan 2015
Study CompletionJan 2015
TodayJul 2026
First PostedSep 25, 2014
Enrollment StartOct 8, 2014
Primary CompletionJan 7, 2015
Study CompletionJan 8, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.8 years ago
Interventions
BI 409306drug
Oral single dose of BI 409306
Itraconazoledrug
Oral dose, twice daily on Day -3, once daily on Day -2 to Day 2 of Itraconazole