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Antimicrobial Agents and Chemotherapy, January 2005, p. 195-201, Vol. 49, No. 1
0066-4804/05/$08.00+0     doi:10.1128/AAC.49.1.195-201.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Pharmacokinetics, Serum Inhibitory and Bactericidal Activity, and Safety of Telavancin in Healthy Subjects

J. P. Shaw,* J. Seroogy, K. Kaniga, D. L. Higgins, M. Kitt, and S. Barriere

Theravance Inc., South San Francisco, California

Received 27 January 2004/ Returned for modification 25 April 2004/ Accepted 15 September 2004

The pharmacokinetics, tolerability, and serum inhibitory and bactericidal titers of telavancin, a new rapidly bactericidal lipoglycopeptide with multiple mechanisms of action against gram-positive pathogens, were assessed in a two-part, randomized, double-blind, placebo-controlled, ascending-dose study with 54 healthy men. In part 1, single ascending intravenous doses of 0.25 to 15 mg/kg of body weight were studied. In part 2, multiple ascending doses (30-min infusions of 7.5 to 15 mg/kg/day) were studied over 7 days. Following the administration of multiple doses, steady state was achieved by days 3 to 4. At day 7 after the administration of telavancin at 7.5, 12.5, and 15 mg/kg/day, peak concentrations in plasma were 96.7, 151.3, and 202.5 µg/ml, respectively, and steady-state area-under-the-curve values were 700, 1,033, and 1,165 µg · h/ml, respectively. The elimination half-life ranged from 6.9 to 9.1 h following the administration of doses ≥5 mg/kg. Most adverse events were mild in severity. At 24 h postinfusion, serum from subjects given telavancin demonstrated potent bactericidal activity against methicillin-resistant Staphylococcus aureus and penicillin-resistant Streptococcus pneumoniae strains. The results suggest that telavancin may be an effective once-daily therapy for serious bacterial infections caused by these pathogens.

* Corresponding author. Mailing address: Theravance, Inc., 901 Gateway Blvd., South San Francisco, CA 94080. Phone: (650) 808-6025. Fax: (650) 808-6441. E-mail: jpshaw{at}theravance.com.

Antimicrobial Agents and Chemotherapy, January 2005, p. 195-201, Vol. 49, No. 1
0066-4804/05/$08.00+0     doi:10.1128/AAC.49.1.195-201.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.



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