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