At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 157 enrolled
Drug / intervention
Dabigatran +2 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, Placebo-controlled Phase I Study in Healthy Male Volunteers. to Investigate Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BI 655075 (Part 1) and to Explore the Dose of BI 655075 Effective to Reverse Dabigatran Anticoagulant Activity (Part 2)
In Brief
A Phase 1 clinical trial evaluating Dabigatran, BI 655075, and 1 other intervention for Healthy. Completed, enrolled 157 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
CountriesBelgium
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2012
First PostedSep 2012
Primary CompletionNov 2013
TodayJul 2026
First PostedSep 20, 2012
Enrollment StartSep 1, 2012
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.8 years ago
Interventions
Dabigatrandrug
BI 655075drug
Placebodrug