NCT01955720

Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran

Randomised, Double-blind, Placebo-controlled, Two-way Cross-over Phase Ib Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655075 and to Establish the Efficacy of BI 655075 in Reversal of Dabigatran Anticoagulant Activity in Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Accepted

Summary

To investigate safety, tolerability, PK and PD of BI 655075 and to establish the BI 655075 dose(s) effective to reverse prolongation of blood coagulation time by dabigatran

Conditions

• Hemorrhage

Interventions

Type	Name	Description
DRUG	BI 655075
DRUG	BI 655075
DRUG	Placebo
DRUG	BI 655075
DRUG	Placebo
DRUG	Placebo
DRUG	Placebo
DRUG	BI 655075

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-05-01
• Completion: 2014-08-01
• First posted: 2013-10-07
• Last updated: 2016-02-11
• Results posted: 2016-02-11

Locations

1 site across 1 country: Belgium