title: 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.affiliation: Cempra Pharmaceuticals Inc., Chapel Hill, North Carolina 27517, USA. prabha@fernandes-domain.com
authors.forename: J Gordon
authors.initials: JG
authors.lastname: Still
authors.forename: Kay
authors.initials: K
authors.lastname: Clark
authors.forename: Thorsten P
authors.initials: TP
authors.lastname: Degenhardt
authors.forename: Drusilla
authors.initials: D
authors.lastname: Scott
authors.forename: Prabhavathi
authors.initials: P
authors.lastname: Fernandes
authors.forename: Maria J
authors.initials: MJ
authors.lastname: Gutierrez
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005672:Fusidic Acid / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D005672:Fusidic Acid