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0091270007307337v1
47/11/1374    most recent
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PHARMACOKINETICS

Influence of Ethnic Origin and Sex on the Pharmacokinetics of Clazosentan

Paul L. M. van Giersbergen, PhD, Kulasiri A. Gunawardena, MD and Jasper Dingemanse, PhD

From Actelion Pharmaceuticals Ltd, Department of Clinical Pharmacology, Allschwil, Switzerland (Dr van Giersbergen, Dr Dingemanse), and Chiltern International Ltd, Slough, Berkshire, United Kingdom (Dr Gunawardena).

This study investigated the influence of ethnic origin and, as a secondary objective, sex on the pharmacokinetics of the parenteral endothelin receptor antagonist clazosentan in healthy Caucasian and Japanese subjects. Twelve subjects of each ethnic origin (female/male ratio 1:1) were treated with sequential 4-hour infusions of 1, 5, and 15 mg/h. Blood samples were taken frequently to determine plasma levels of clazosentan. The exposure to clazosentan was approximately 16% higher in Japanese subjects compared with Caucasian subjects and 18% higher in females compared with males. These differences were mainly attributable to a difference in clearance. A 3-compartment model well described the plasma concentration-time profiles of clazosentan with disposition half-lives of approximately 6 minutes, 21 minutes, and 2.7 hours. The data suggest that Caucasian and Japanese patients can be treated with a similar dosing regimen of clazosentan. At the doses infused, administration of clazosentan was safe and well tolerated in both ethnic groups.

Key Words: Clazosentan • endothelin • ethnic origin • sex • pharmacokinetics

Address for correspondence: Paul L. M. van Giersbergen, PhD, Actelion Pharmaceuticals Ltd, Department of Clinical Pharmacology, Gewerbestrasse 16, 4123 Allschwil, Switzerland.


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