CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
BI 1026706 +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.

Search/NCT02513446
NCT02513446Phase 1Completed
CompareCT.gov

Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1026706 in Healthy Male Subjects (an Open-label, Randomised, Two-period, Two-sequence Crossover Study)

Boehringer Ingelheim·interventional·Posted Jul 31, 2015·Updated Mar 29, 2019

In Brief

A Phase 1 clinical trial evaluating BI 1026706 and Itraconazole for Healthy. Completed, enrolled 16 participants across 1 site.

Detailed Summary

The primary objective of this trial is to investigate the effect of multiple doses of itraconazole on the pharmacokinetics of BI 1026706 given as single dose. The assessment of safety and tolerability of BI 1026706 is an additional objective of this trial. Furthermore, the pharmacokinetics of the metabolite BI 1072668 will be explored.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 31, 2015
Enrollment StartSep 29, 2015
Primary CompletionNov 14, 2015
Study CompletionNov 20, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.9 years ago

Interventions

BI 1026706drug

Single dose of BI 1026706 on Day 1

Itraconazoledrug

7 days of itraconazole treatment combined with a single dose of BI 1026706 on the fourth day