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, 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

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.).

Figures

**FIG 1**
Solithromycin plasma concentration versus time after dose in adolescents. Each line denotes an individual subject concentration versus time curve.

**FIG 2**
Dried blood spot versus plasma solithromycin concentrations are displayed. The solid and dashed black lines denote the line of unity and linear fit, respectively.

Source: PubMed

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

Abstract

Figures

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