Clinical safety, tolerability, pharmacokinetics, and pharmacodynamics of the novel factor Xa inhibitor edoxaban in healthy volunteers

Journal of Clinical Pharmacology

Volumn 50, Issue 7, 2010, Pages 743-753

  Ogata, Koichiro ^a   Mendell Harary, Jeanne ^b   Tachibana, Masaya ^a   Masumoto, Hiroshi ^a   Oguma, Toshihiro ^a   Kojima, Masazumi ^a   Kunitada, Satoshi ^a  

^a DAIICHI SANKYO CO   (Japan)

^b DAIICHI SANKYO INC   (United States)

Author keywords

Atrial fibrillation; DU 176b; Edoxaban; Factor Xa inhibitor; Venous thromboembolism

Indexed keywords

BLOOD CLOTTING FACTOR 10A INHIBITOR; EDOXABAN; PLACEBO; UNCLASSIFIED DRUG;

ARTICLE; BLEEDING; BLEEDING TIME; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG DOSE COMPARISON; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; HEADACHE; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; PROTHROMBIN TIME; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE BLIND PROCEDURE; SWEATING; SYNCOPE;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; ANTICOAGULANTS; AREA UNDER CURVE; BLEEDING TIME; DOSE-RESPONSE RELATIONSHIP, DRUG; FACTOR XA; FOOD-DRUG INTERACTIONS; HALF-LIFE; HUMANS; INTERNATIONAL NORMALIZED RATIO; MALE; MIDDLE AGED; PARTIAL THROMBOPLASTIN TIME; PROTHROMBIN TIME; PYRIDINES; SINGLE-BLIND METHOD; TABLETS; THIAZOLES; YOUNG ADULT;

EID: 77953787643     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270009351883     Document Type: Article

References (13)

1. du Breuil AL, Umland EM Outpatient management of anticoagulation therapy. Am Fam Physician. 2007 ; 75: 1031-1042.
2. Connolly SJ, Eikelboom J., O'Donnell M., Pogue J., Yusuf S. Challenges of establishing new antithrombotic therapies in atrial fibrillation. Circulation. 2007 ; 116: 449-455.
3. Eikelboom JW, Weitz JI A replacement for warfarin: the search continues. Circulation. 2007 ; 116: 131-133.
4. Ansell J. Factor Xa or thrombin: is factor Xa a better target? J Thromb Haemost. 2007 ; 5 (suppl 1). 60-64.
5. Kunitada S., Nagahara T., Hara T. Inhibitors of factor Xa. In: Uprichard ACG, Gallagher KP, eds. Handbook of Experimental Pharmacology, Vol 132. Antithrombotics. Berlin, Germany: Springer ; 1998 ; 397-420.
6. Nagahara T., Yokoyama Y., Inamura K., et al. Dibasic (amidinoaryl) propanoic acid derivatives as novel blood coagulation factor Xa inhibitors. J Med Chem. 1994 ; 37: 1200-1207.
7. Alexander JH, Yang H., Becker RC, et al. First experience with direct, selective factor Xa inhibition in patients with non-ST-elevation acute coronary syndromes: results of the XaNADU-ACS Trial. J Thromb Haemost. 2005 ; 3: 439-447.
8. Shimbo D., Osende J., Chen J., et al. Antithrombotic effects of DX-9065a, a direct factor Xa inhibitor: a comparative study in humans versus low molecular weight heparin. Thromb Haemost. 2002 ; 88: 733-738.
9. Zafar MU, Vorchheimer DA, Gaztanaga J., et al. Antithrombotic effects of factor Xa inhibition with DU-176b: phase-I study of an oral, direct factor Xa inhibitor using an ex-vivo flow chamber. Thromb Haemost. 2007 ; 98: 883-888.
10. Furugohri T., Isobe K., Honda Y., et al. DU-176b, a potent and orally active factor Xa inhibitor: in vitro and in vivo pharmacological profiles. J Thromb Haemost. 2008 ; 6: 1542-1549.
11. Fda, Cder. Food-Effect Bioavailability and Fed Bioequivalence Studies. Guidance for Industry. http://www.fda.gov/cder/guidance/5194fnl.htm#-ftn5191. December 2002. Accessed February 10, 2009.
12. Newman BH Vasovagal reaction rates and body weight: findings in high and low-risk populations. Transfusion. 2003 ; 43: 1084-1088.
13. Zafar MU, Viles-Gonzalez J., Valdiviezo C., et al. Tissue factor pathway inhibition, a new antithrombotic strategy: phase-II study of a novel, oral factor Xa inhibitor. JACC. 2004 ; 43 (suppl A): 443A.