At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 80 enrolled
Drug / intervention
Placebo to dose +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.
Randomised, Double-blind Within Dose Groups, Placebo-controlled Phase I Trial in Healthy Japanese Male Volunteers to Investigate Safety, Tolerability and Pharmacokinetics of Different Doses of BI 655075 (Part 1) and to Explore the Effective Dose of BI 655075 to Reverse Dabigatran Anticoagulant Activity (Part 2).
In Brief
A Phase 1 clinical trial evaluating Placebo to dose, Idarucizumab, and 2 other interventions for Healthy. Completed, enrolled 80 participants across 1 site.
Detailed Summary
The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI 655075 following intravenous administration of single rising doses of BI 655075 when administered alone and after administration of dabigatran.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJan 2014
First PostedJan 2014
Primary CompletionAug 2014
TodayJul 2026
First PostedJan 7, 2014
Enrollment StartJan 1, 2014
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.5 years ago
Interventions
Placebo to dosedrug
placebo
Idarucizumabdrug
short infusion
Placebo to Idarucizumabdrug
Placebo to Idarucizumab
dabigatrandrug
2 capsules dabigatran
Idarucizumabdrug
short infusion