1.
Antimicrob Agents Chemother
; 60(4): 2572-6, 2016 Apr.
Artigo
em Inglês
| MEDLINE
| ID: mdl-26883693
RESUMO
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.).