At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 14 enrolled
Drug / intervention
BI 1815368 +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.
Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1815368 in Healthy Male Subjects (an Open-label, Two-period Fixed-sequence Design Study)
In Brief
A Phase 1 clinical trial evaluating BI 1815368 and Itraconazole for Healthy. Completed, enrolled 14 participants across 1 site.
Detailed Summary
The main objective of this trial is to investigate the effect on the exposure of BI 1815368 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
202420252026
First PostedJul 2023
Enrollment StartAug 2023
Primary CompletionOct 2023
TodayJul 2026
First PostedJul 28, 2023
Enrollment StartAug 2, 2023
Primary CompletionOct 24, 2023
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 2.9 years ago
Interventions
BI 1815368drug
BI 1815368
Itraconazoledrug
Itraconazole