Pharmacokinetic/pharmacodynamic relationships for otamixaban, a direct factor Xa inhibitor, in healthy subjects

Journal of Clinical Pharmacology

Volumn 46, Issue 1, 2006, Pages 45-51

  Paccaly, Anne ^a   Frick, Annke ^b   Ozoux, Marie Laure ^b   Chu, Valeria ^a   Rosenburg, Ronald ^b   Hinder, Markus ^b   Shukla, Umesh ^a,c   Jensen, Bradford K ^a  

^a SANOFI   (France)

^b Johnson and Johnson Pharmaceutical Research and Development ^*

^c JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

Anticoagulants; Antithrombotic agents; Otamixaban; Pharmacodynamic; Pharmacokinetics

Indexed keywords

BLOOD CLOTTING FACTOR 10A INHIBITOR; OTAMIXABAN; PLACEBO; SNAKE VENOM; UNCLASSIFIED DRUG;

ADULT; ANTICOAGULATION; ARTICLE; BLOOD CLOTTING TIME; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG MECHANISM; HUMAN; MALE; NORMAL HUMAN; PARTIAL THROMBOPLASTIN TIME; PROTHROMBIN TIME; RANDOMIZED CONTROLLED TRIAL;

EID: 29744470027     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270005281818     Document Type: Article

References (8)

1. Chu V, Brown K, Colussi D, Gao J, Bostwick J, Kasiewski C, et al. Pharmacological characterization of a novel factor Xa inhibitor, FXV673. Thromb Res. 2001;103(4):309-324.
2. Paccaly A, Ozoux M-L, Chu V, Simcox K, Marks V, Freyburger G, et al. Pharmacodynamic markers in the early clinical assessment of otamixahan, a direct factor Xa inhibitor. Accepted Thromb and Haemost. 2005. [tentatively Dec 2005]
3. Paccaly A, Frick A, Rohatagi S, Liu J, Shukla U, Rosenburg R, et al. Pharmacokinetics of otamixaban, a direct factor Xa inhibitor, in healthy male subjects: pharmacokinetic model development for phase II/III simulation of exposure. Accepted J Clin Pharmacol. 2005;46:37-44.
4. Paccaly A, Ozoux M-L, Frick A, Rosenburg R, B.K. J. Pharmacokinetic/ pharmacodynamic relationships for factor Xa-in-hibitor XRP0673 in early drug development (Abstract). J Pharm Sci. 2002;4(4):W5241.
5. Paccaly A, Frick A, Hinder M, Dejongh J, Danhof M, Maas J. Population PK/PD model for otamixaban, a novel specific FXa inhibitor (Abstract). Accepted J. Pharm Sci. 2005.
6. Gaussem P, Dubar M, le Bonniec B, Richard-Lordereau I, Jochemsen R, Aiach M. Dose-effect relationship for several coagulation markers during administration of the direct thrombin inhibitor S 18326 in healthy subjects. Br J Clin Pharmacol. 2002;53(2):147-154.
7. Cullberg M, Eriksson UG, Larsson M, Karlsson MO. Population modelling of the effect of inogatran, at thrombin inhibitor, on ex vivo coagulation time (APTT) in healthy subjects and patients with coronary artery disease. Br J Clin Pharmacol. 2001;51(1):71-79.
8. Stern R, Chanoine F, Criswell K. Are coagulation times biomarkers? Data from a phase I study of the oral thrombin inhibitor LB-30057 (CI-1028). J Clin Pharmacol. 2003;43(2):118-121.