drugset / Trial / NCT02028780
Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 (Idarucizumab) Administered Alone or With Dabigatran Etexilate in Japanese Healthy Subjects
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2014-01
- Primary completion
- 2014-08
- Completion
- 2014-08
Publications
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Idarucizumab | Monoclonal antibody | 1 g | Intravenous |
| Subject | Idarucizumab | Monoclonal antibody | 2 g | Intravenous |
| Subject | Idarucizumab | Monoclonal antibody | 4 g | Intravenous |
| Subject | Idarucizumab | Monoclonal antibody | 5 g | Intravenous |
| Subject | Idarucizumab | Monoclonal antibody | 8 g | Intravenous |
| Background | Dabigatran | Unknown | 220 mg | — |
Indications
No indication recorded.