Are Coagulation Times Biomarkers? Data from a Phase I Study of the Oral Thrombin Inhibitor LB-30057 (CI-1028)

Ecarin clotting time and activated partial thromboplastin time are coagulation tests that meet the definition of a biomarker. Prolongation of these coagulation times closely correlated with blood concentrations of the oral thrombin inhibitor LB‐30057 (CI‐1028) during a phase 1 study. But this simply...

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Bibliographic Details
Published in:Journal of clinical pharmacology 2003-02, Vol.43 (2), p.118-121
Main Authors: Stern, Ralph, Chanoine, Francoise, Criswell, Kay
Format: Article
Language:English
Subjects:
Administration, Oral
Benzamides - blood
Benzamides - pharmacokinetics
Benzamides - pharmacology
Biological and medical sciences
Biomarkers
Blood Coagulation - drug effects
Blood. Blood coagulation. Reticuloendothelial system
Dose-Response Relationship, Drug
Double-Blind Method
Female
Half-Life
Humans
Male
Medical sciences
Pharmacology. Drug treatments
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Summary:Ecarin clotting time and activated partial thromboplastin time are coagulation tests that meet the definition of a biomarker. Prolongation of these coagulation times closely correlated with blood concentrations of the oral thrombin inhibitor LB‐30057 (CI‐1028) during a phase 1 study. But this simply reflects their functioning as enzyme inhibition assays of drug concentration. Directly adding the drug to blood results in the same concentration‐response relationship. Changes in coagulation tests only demonstrate that ex vivo clot formation has been altered, not that an in vivo process has been affected. To be most informative in drug development, biomarker assays should measure in vivo drug effects, not drug concentrations.
ISSN:0091-2700
1552-4604
DOI:10.1177/0091270002239818