title: Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents.
abstract: We assessed the pharmacokinetics and safety of solithromycin, a fluoroketolide antibiotic, in a phase 1, open-label, multicenter study of 13 adolescents with suspected or confirmed bacterial infections. On days 3 to 5, the mean (standard deviation) maximum plasma concentration and area under the concentration versus time curve from 0 to 24 h were 0.74 μg/ml (0.61 μg/ml) and 9.28 μg · h/ml (6.30 μg · h/ml), respectively. The exposure and safety in this small cohort of adolescents were comparable to those for adults. (This study has been registered at ClinicalTrials.gov under registration no. NCT01966055.).
authors.affiliation: Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Gonzalez
authors.affiliation: Infectious Diseases Section, Baylor College of Medicine, Houston, Texas, USA.
authors.forename: Debra L
authors.initials: DL
authors.lastname: Palazzi
authors.affiliation: Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.
authors.forename: Leena
authors.initials: L
authors.lastname: Bhattacharya-Mithal
authors.affiliation: Oregon Health & Science University, Portland, Oregon, USA.
authors.forename: Amira
authors.initials: A
authors.lastname: Al-Uzri
authors.affiliation: Arkansas Children's Hospital Research Institute, Little Rock, Arkansas, USA.
authors.forename: Laura P
authors.initials: LP
authors.lastname: James
authors.affiliation: University of California San Diego Medical Center, San Diego, California, USA.
authors.forename: John
authors.initials: J
authors.lastname: Bradley
authors.affiliation: Columbia University Medical Center, New York, New York, USA.
authors.forename: Natalie
authors.initials: N
authors.lastname: Neu
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
authors.forename: Theresa
authors.initials: T
authors.lastname: Jasion
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA.
authors.forename: Christoph P
authors.initials: CP
authors.lastname: Hornik
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA.
authors.forename: P Brian
authors.initials: PB
authors.lastname: Smith
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA.
authors.forename: Daniel K
authors.initials: DK
authors.lastname: Benjamin
authors.affiliation: Cempra, Inc., Chapel Hill, North Carolina, USA.
authors.forename: Kara
authors.initials: K
authors.lastname: Keedy
authors.affiliation: Cempra, Inc., Chapel Hill, North Carolina, USA.
authors.forename: Prabhavathi
authors.initials: P
authors.lastname: Fernandes
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA michael.cohenwolkowiez@duke.edu.
authors.forename: Michael
authors.initials: M
authors.lastname: Cohen-Wolkowiez
mesh_terms: D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001424:Bacterial Infections / Q000097:blood / Q000188:drug therapy*; D002648:Child; D059788:Dried Blood Spot Testing; D005260:Female; D006801:Humans; D018942:Macrolides / Q000097:blood / Q000493:pharmacokinetics*; D008297:Male; D061214:Patient Safety; D014230:Triazoles / Q000097:blood / Q000493:pharmacokinetics*
chemical_list: D000900:Anti-Bacterial Agents; D018942:Macrolides; D014230:Triazoles; C547755:solithromycin