At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 14 enrolled
Drug / intervention
BI 474121 +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 474121 in Healthy Male Subjects (an Open-label, Two-period Fixed Sequence Design Study)
In Brief
A Phase 1 clinical trial evaluating BI 474121 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 474121 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
202120222023202420252026
First PostedJan 2021
Enrollment StartFeb 2021
Primary CompletionApr 2021
TodayJul 2026
First PostedJan 20, 2021
Enrollment StartFeb 1, 2021
Primary CompletionApr 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 5.5 years ago
Interventions
BI 474121drug
BI 474121 oral solution
Itraconazoledrug
Itraconazole oral solution