At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 14 enrolled
Drug / intervention
BI 1323495 +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.
Relative Bioavailability of a Single Oral Dose of BI 1323495 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects (an Open-label, One-way Crossover Study)
In Brief
A Phase 1 clinical trial evaluating BI 1323495 and Itraconazole for Healthy. Completed, enrolled 14 participants across 1 site.
Detailed Summary
The main objective of this trial is to investigate the relative bioavailability of BI 1323495 in plasma when given as oral single dose together with multiple oral doses of itraconazole (Test,T) as compared to when given alone as oral single dose (Reference, R).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedJul 2019
Enrollment StartJul 2019
Primary CompletionSep 2019
TodayJul 2026
First PostedJul 8, 2019
Enrollment StartJul 24, 2019
Primary CompletionSep 6, 2019
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 7.0 years ago
Interventions
BI 1323495drug
Tablet
Itraconazoledrug
Oral solution