Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 (Idarucizumab) Administered Alone or With Dabigatran Etexilate in Japanese Healthy Subjects
NCT ID: NCT02028780
Last Updated: 2016-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
80 participants
INTERVENTIONAL
2014-01-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Idarucizumab single doses
different infusion durations
Placebo to dose
placebo
Idarucizumab
short infusion
Idarucizumab with dabigatran
short infusion with 2 capsules dabigatran
Idarucizumab
short infusion
Placebo to Idarucizumab
Placebo to Idarucizumab
dabigatran
2 capsules dabigatran
Interventions
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Placebo to dose
placebo
Idarucizumab
short infusion
Placebo to Idarucizumab
Placebo to Idarucizumab
dabigatran
2 capsules dabigatran
Idarucizumab
short infusion
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
45 Years
MALE
Yes
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1321.5.00001 Boehringer Ingelheim Investigational Site
Sumida-ku, Tokyo, , Japan
Countries
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References
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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.
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.
Other Identifiers
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1321.5
Identifier Type: -
Identifier Source: org_study_id
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