At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 34 enrolled
Drug / intervention
Nintedanib +5 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 Nintedanib Given Alone and in Combination With Ketoconazole at Steady State in Healthy Male Volunteers (an Open-label, Randomised, Two-way Cross-over Clinical Phase I Study)
In Brief
A Phase 1 clinical trial evaluating Nintedanib and Ketoconazole for Healthy. Completed, enrolled 34 participants across 1 site.
Detailed Summary
The objective of the current study is to investigate the relative bioavailability of a single dose of nintedanib low or high dose with and without coadministration of ketoconazole at steady state
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2012
First PostedSep 2012
Primary CompletionNov 2012
TodayJul 2026
First PostedSep 6, 2012
Enrollment StartSep 1, 2012
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.8 years ago
Interventions
Nintedanibdrug
low or medium dose depending on pilot part
Nintedanibdrug
low dose oral administration
Ketoconazoledrug
oral administration
Nintedanibdrug
low dose oral administration
Nintedanibdrug
low or medium dose depending on pilot part
Ketoconazoledrug
oral administration