Clinical trial NCT02028780: Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 (Idarucizumab) Administered Alone or With Dabigatran Etexilate in Japanese Healthy Subjects
Official title: 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-01-07
Enrollment: 80
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

1. Healthy Japanese male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: Percentage of Subjects With Drug-related Adverse Events in Part 1 and Part 2
timeFrame: From first drug administration until 13 weeks after the last drug administration, upto 98 days (Part-I) & upto 108 days (Part-II)
Secondary outcomes:
measure: Ae0-74,ss on Days 4 and 11 for Sum Dabigatran (Part II)
timeFrame: 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.
measure: AUC2-12,ss on Days 4 and 11 for Unbound Sum Dabigatran (Part II).
timeFrame: Day 4 (Part I) and Day 11 (Part II). Time frame are provided in detail in the Description section
measure: Cmax for Idarucizumab in the Part I & Part II.
timeFrame: Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section
measure: AUC0-inf for Idarucizumab in the Part I & Part II.
timeFrame: Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section
measure: Ae0-72 for Idarucizumab in the Part I & Part II.
timeFrame: Day 1 to 4 (Part I) and Day 11 to 14 (Part II); Time frame are provided in detail in the Description section
measure: Ae0-73 for the Dose Group 4 in the Part I
timeFrame: For dose group 4 (day1 to day4-Part-1): 0-7h, 7-13h, 13-25h, 25-49h, 49-73h
measure: AUEC2-12
timeFrame: Day 4 and Day 11 (Part II); Time frame are provided in detail in the Description section
Other outcomes:
Locations:
city: Sumida-ku, Tokyo
country: Japan
facility: 1321.5.00001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Yasaka M, Ikushima I, Harada A, Imazu S, Taniguchi A, Norris S, Gansser D, Stangier J, Schmohl M, Reilly PA. Safety, pharmacokinetics and pharmacodynamics of idarucizumab, a specific dabigatran reversal agent in healthy Japanese volunteers: a randomized study. Res Pract Thromb Haemost. 2017 Aug 5;1(2):202-215. doi: 10.1002/rth2.12029. eCollection 2017 Oct.
citation: Norris S, Ramael S, Ikushima I, Haazen W, Harada A, Moschetti V, Imazu S, Reilly PA, Lang B, Stangier J, Glund S. Evaluation of the immunogenicity of the dabigatran reversal agent idarucizumab during Phase I studies. Br J Clin Pharmacol. 2017 Aug;83(8):1815-1825. doi: 10.1111/bcp.13269. Epub 2017 Apr 6.