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).
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Percentage of Subjects With Drug-related Adverse Events in Part 1 and Part 2
Study Overview
Brief 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Idarucizumab single doses
different infusion durations
Intervention: Placebo to dose (Drug)
Idarucizumab single doses
different infusion durations
Intervention: Idarucizumab (Drug)
Idarucizumab with dabigatran
short infusion with 2 capsules dabigatran
Intervention: Idarucizumab (Drug)
Idarucizumab with dabigatran
short infusion with 2 capsules dabigatran
Intervention: Placebo to Idarucizumab (Drug)
Idarucizumab with dabigatran
short infusion with 2 capsules dabigatran
Intervention: dabigatran (Drug)
Outcomes
Primary Outcomes
Percentage of Subjects With Drug-related Adverse Events in Part 1 and Part 2
Time Frame: From first drug administration until 13 weeks after the last drug administration, upto 98 days (Part-I) & upto 108 days (Part-II)
Percentage of subjects with drug-related adverse events in Part 1 and Part 2.
Secondary Outcomes
- Ae0-74,ss on Days 4 and 11 for Sum Dabigatran (Part II)(0-2 h, 2-6 h, 6-10 h, 10-12 h,12-14h, 14-26 h, 26-50 h, 50-74 h after drug administration of dabigatran etexilate on Day 4 and Day 11.)
- Cmax for Idarucizumab in the Part I & Part II.(Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section)
- AUC0-inf for Idarucizumab in the Part I & Part II.(Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section)
- AUC2-12,ss on Days 4 and 11 for Unbound Sum Dabigatran (Part II).(Day 4 (Part I) and Day 11 (Part II). Time frame are provided in detail in the Description section)
- AUEC2-12(Day 4 and Day 11 (Part II); Time frame are provided in detail in the Description section)
- Ae0-73 for the Dose Group 4 in the Part I(For dose group 4 (day1 to day4-Part-1): 0-7h, 7-13h, 13-25h, 25-49h, 49-73h)
- Ae0-72 for Idarucizumab in the Part I & Part II.(Day 1 to 4 (Part I) and Day 11 to 14 (Part II); Time frame are provided in detail in the Description section)