drugset / Trial / NCT01688830
Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 Administered Alone or With Dabigatran Etexilate
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
- 2012-09
- Primary completion
- 2013-11
- Completion
- 2013-11
Publications
- 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.
- Glund S, Stangier J, Schmohl M, Gansser D, Norris S, van Ryn J, Lang B, Ramael S, Moschetti V, Gruenenfelder F, Reilly P, Kreuzer J. Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: a randomised, placebo-controlled, double-blind phase 1 trial. Lancet. 2015 Aug 15;386(9994):680-90. doi: 10.1016/S0140-6736(15)60732-2. Epub 2015 Jun 15.
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 | 7.5 g | Intravenous |
| Background | Dabigatran | Unknown | 220 mg | Oral |
Indications
No indication recorded.