At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 14 enrolled
Drug / intervention
BI 730357 +1 moredrug
Likely dose
BI 730357 0 mgfrom 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 730357 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 730357 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 730357 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
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartJan 2019
Primary CompletionMar 2019
TodayJul 2026
First PostedDec 20, 2018
Enrollment StartJan 10, 2019
Primary CompletionMar 11, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.5 years ago
Interventions
BI 730357drug
0 mg BI 730357 tablet orally on Day 1
Itraconazoledrug
20 mL of 10 mg/ mL Itraconazole oral solution in treatment period 2 only (T). Itraconazole was administered once daily for 12 days from Day -3 to Day 9.