Pharmacokinetics and safety of single, multiple, and loading doses of fusidic acid in healthy subjects.

Abstract

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.

• Authors: J Gordon Still, Kay Clark, Thorsten P Degenhardt, Drusilla Scott, Prabhavathi Fernandes, Maria J Gutierrez
• Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 52 Suppl 7 Pg. S504-12 (Jun 2011) ISSN: 1537-6591 [Electronic] United States
• PMID: 21546627 (Publication Type: Clinical Trial, Phase I, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Fusidic Acid

Topics

• Administration, Oral
• Adolescent
• Adult
• Anti-Bacterial Agents (administration & dosage, adverse effects, pharmacokinetics)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Female
• Fusidic Acid (administration & dosage, adverse effects, pharmacokinetics)
• Humans
• Male
• Middle Aged
• Treatment Outcome
• Young Adult