Journal Article

Pharmacokinetics and Safety of Single, Multiple, and Loading Doses of Fusidic Acid in Healthy Subjects

J. Gordon Still, Kay Clark, Thorsten P. Degenhardt, Drusilla Scott, Prabhavathi Fernandes and Maria J. Gutierrez

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 52, issue suppl_7, pages S504-S512
Published in print June 2011 | ISSN: 1058-4838
Published online June 2011 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1093/cid/cir174
Pharmacokinetics and Safety of Single, Multiple, and Loading Doses of Fusidic Acid in Healthy Subjects

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A phase 1 trial of fusidic acid (CEM-102), an oral fusidane class antibiotic under development for treatment of gram-positive acute bacterial skin and skin structure infections, evaluating pharmacokinetics and safety is described. A randomized, double-blinded, placebo-controlled, dose escalation study was conducted in healthy adult subjects in the fasting state. Plasma exposure after multiple doses was higher than for single doses, indicating accumulation. Loading doses designed to optimize pharmacodynamic effects were well tolerated and achieved near-steady state concentrations of CEM-102 at 24 h. CEM-102 was safe and generally well tolerated at all single, multiple, and loading doses administered.

Journal Article.  5435 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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