At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
BI 113608 +4 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 Single Oral Dose of BI 113608 When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole or Voriconazole in Healthy Male Subjects (an Open-label, Randomised, Three-period Cross-over Trial)
In Brief
A Phase 1 clinical trial evaluating BI 113608, Ketoconazole, and 1 other intervention for Healthy. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The primary objective of this trial is to investigate the relative bioavailability of a single oral dose of BI 113608 without and with ketoconazole and voriconazole at steady state. The assessment of safety and tolerability of BI 113608 administered alone and upon co-administration will be an additional objective of this trial.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2013
First PostedFeb 2013
Primary CompletionApr 2013
TodayJul 2026
First PostedFeb 8, 2013
Enrollment StartJan 1, 2013
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 13.4 years ago
Interventions
BI 113608drug
tablet
BI 113608drug
tablet
BI 113608drug
tablet
Ketoconazoledrug
tablet
Voriconazoledrug
tablet