Solithromycin pharmacokinetics in plasma and dried blood spots and safety in adolescents

Daniel Gonzalez, Debra L. Palazzi, Leena Bhattacharya-Mithal, Amira Al-Uzri, Laura P. James, John Bradley, Natalie Neu, Theresa Jasion, Christoph P. Hornik, P. Brian Smith, Daniel K. Benjamin, Jr Kara Keedy, Prabhavathi Fernandes, Michael Cohen-Wolkowiez

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11 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)2572-2576
Number of pages5
JournalAntimicrobial agents and chemotherapy
Volume60
Issue number4
DOIs
StatePublished - Apr 2016

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Infectious Diseases

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    Gonzalez, D., Palazzi, D. L., Bhattacharya-Mithal, L., Al-Uzri, A., James, L. P., Bradley, J., Neu, N., Jasion, T., Hornik, C. P., Smith, P. B., Benjamin, D. K., Keedy, J. K., Fernandes, P., & Cohen-Wolkowiez, M. (2016). Solithromycin pharmacokinetics in plasma and dried blood spots and safety in adolescents. Antimicrobial agents and chemotherapy, 60(4), 2572-2576. https://doi.org/10.1128/AAC.02561-15