Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents.

Journal Article (Journal Article;Multicenter Study)

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.).

Full Text

Duke Authors

Cited Authors

  • Gonzalez, D; Palazzi, DL; Bhattacharya-Mithal, L; Al-Uzri, A; James, LP; Bradley, J; Neu, N; Jasion, T; Hornik, CP; Smith, PB; Benjamin, DK; Keedy, K; Fernandes, P; Cohen-Wolkowiez, M

Published Date

  • April 2016

Published In

Volume / Issue

  • 60 / 4

Start / End Page

  • 2572 - 2576

PubMed ID

  • 26883693

Pubmed Central ID

  • PMC4808196

Electronic International Standard Serial Number (EISSN)

  • 1098-6596

Digital Object Identifier (DOI)

  • 10.1128/AAC.02561-15

Language

  • eng

Conference Location

  • United States