J Clin Pharmacol
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PHARMACOGENETICS

Lack of Weight-Based Dose Dependency and Intraindividual Variability of Omeprazole for CYP2C19 Phenotyping

Myong-Jin Kim, PharmD, Anne N. Nafziger, MD, MHS, Yanhua Zhang, MD, MSc, Edward M. Sellers, MD, PhD, Andrea Gaedigk, PhD and Joseph S. Bertino, Jr, PharmD, FCP

From the Clinical Pharmacology Research Center (Dr. Kim, Dr. Nafziger, Dr. Bertino), Department of Medicine (Dr. Nafziger, Dr. Bertino), Bassett Healthcare, Cooperstown, New York; Department of Pharmacology (Dr. Zhang, Dr. Sellers), Psychopharmacology and Dependence Research Unit (Dr. Sellers), Sunny Brook & Women's College, University of Toronto, Toronto, Ontario, Canada; and Section of Clinical Pharmacology and Experimental Therapeutics, The Children's Mercy Hospital, Kansas City, Missouri (Dr. Gaedigk). Originating Institution: Clinical Pharmacology Research Center, Bassett Healthcare, Cooperstown, New York.

To determine if dose dependency occurs with 2 weight-based single doses of omeprazole in a phenotyping study, as well as to quantitate 3-month intraindividual variability of CYP2C19 activity, 24 Caucasian subjects with body weights from 45 to 66 kg and 67 to 90 kg received single oral 30-mg and 40-mg doses of omeprazole, respectively. Female subjects were phenotyped during the mid-follicular and mid-luteal phases of their menstrual cycles for 3 complete cycles. Male subjects were phenotyped every 14 days for 12 weeks. Subjects with a body weight between 45 and 66 kg received an additional 40-mg omeprazole single dose on visit 7. The 2-hour postdose plasma concentration ratio of omeprazole to 5-hydroxyomeprazole was used as a measure of CYP2C19 activity. The percent coefficient of variation (CV%) of omeprazole phenotyping ranged from 6.3% to 51.3% (median = 18.5%, interquartile range = 14.8%-23.5%). Weight-based single doses of omeprazole for CYP2C19 phenotyping did not exhibit dose dependency. Therefore, a weight-based approach may improve the quantitation of omeprazole/metabolites.

Key Words: CYP2C19 • dose dependency • omeprazole • intrasubject variability

Address for reprints: Joseph S. Bertino Jr., PharmD, FCP, Clinical Pharmacology Research Center, Bassett Healthcare, One Atwell Road, Cooperstown, NY 13326-1394.




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