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Evaluation of the immunogenicity of the dabigatran reversal agent idarucizumab during Phase I studies.

Authors
  • Norris, Stephen1
  • Ramael, Steven2
  • Ikushima, Ippei3
  • Haazen, Wouter2
  • Harada, Akiko4
  • Moschetti, Viktoria5
  • Imazu, Susumu4
  • Reilly, Paul A1
  • Lang, Benjamin6
  • Stangier, Joachim6
  • Glund, Stephan6
  • 1 Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA.
  • 2 SGS Life Sciences Clinical Research Services, Clinical Pharmacology Unit, Antwerp, Belgium. , (Belgium)
  • 3 Department of Internal Medicine, Souseikai Global Clinical Research Center, Sumida Hospital, LTA Medical Corp, Tokyo, Japan. , (Japan)
  • 4 Nippon Boehringer Ingelheim Co. Ltd, Tokyo, Japan. , (Japan)
  • 5 Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany. , (Germany)
  • 6 Boehringer Ingelheim GmbH & Co. KG, Biberach an der Riß, Germany. , (Germany)
Type
Published Article
Journal
British Journal of Clinical Pharmacology
Publisher
Wiley (Blackwell Publishing)
Publication Date
Aug 01, 2017
Volume
83
Issue
8
Pages
1815–1825
Identifiers
DOI: 10.1111/bcp.13269
PMID: 28230262
Source
Medline
Keywords
License
Unknown

Abstract

Pre-existing and treatment-emergent ADA were present at extremely low levels relative to the idarucizumab dosage under evaluation. The PK/PD of idarucizumab appeared to be unaffected by the presence of pre-existing ADA.

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