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Population Pharmacokinetics of Tigecycline in Healthy Volunteers

From Cognigen Corporation, Buffalo, New York (Mr Van Wart, Ms Cirincione, Dr Ludwig, Dr Meagher, Dr Owen); Wyeth Research, Collegeville, Pennsylvania (Dr Korth-Bradley); and Auburn University, Auburn, Alabama (Dr Owen). Dr Meagher's current affiliation is Roswell Park Cancer Institute, Buffalo, New York.

Tigecycline, a novel glycylcycline, possesses broad-spectrum antimicrobial activity. A structural population pharmacokinetic model for tigecycline was developed based on data pooled from 5 phase I studies. Intravenous tigecycline was administered as single (12.5-300 mg) or multiple (25-100 mg) doses every 12 hours for up to 10 days. Three-compartment models with zero-order input and first-order elimination separately described the single- or multiple-dose full-profile data. Additional models were evaluated using a subset of the phase I data mimicking the phase II/III trial sparse-sampling scheme and dosage. A 2-compartment model best described the reduced phase I data following single or multiple doses and provided reliably accurate estimates of tigecycline AUC_0-12. This modeling supported phase II/III population pharmacokinetic model development to further determine individual patient tigecycline exposures for safety and efficacy analyses.

Key Words: Tigecycline • pharmacokinetics • phase I

Address for reprints: Scott Van Wart, MS, Assistant Director, PK/PD, Cognigen Corporation, 395 Youngs Road, Buffalo, NY 14221; e-mail: scott.vanwart{at}cognigencorp.com.

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