TY - JOUR
T1 - Solithromycin pharmacokinetics in plasma and dried blood spots and safety in adolescents
AU - Gonzalez, Daniel
AU - Palazzi, Debra L.
AU - Bhattacharya-Mithal, Leena
AU - Al-Uzri, Amira
AU - James, Laura P.
AU - Bradley, John
AU - Neu, Natalie
AU - Jasion, Theresa
AU - Hornik, Christoph P.
AU - Smith, P. Brian
AU - Benjamin, Daniel K.
AU - Keedy, Jr Kara
AU - Fernandes, Prabhavathi
AU - Cohen-Wolkowiez, Michael
N1 - Funding Information:
This research was sponsored by the U.S. Biomedical Advanced Research and Development Authority (HHSO100201300009C), which has a contract with Cempra, Inc., to perform the study.
Publisher Copyright:
Copyright © 2016, American Society for Microbiology. All Rights Reserved.
PY - 2016/4
Y1 - 2016/4
N2 - 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.
AB - 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.
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U2 - 10.1128/AAC.02561-15
DO - 10.1128/AAC.02561-15
M3 - Article
C2 - 26883693
AN - SCOPUS:84963626437
SN - 0066-4804
VL - 60
SP - 2572
EP - 2576
JO - Antimicrobial Agents and Chemotherapy
JF - Antimicrobial Agents and Chemotherapy
IS - 4
ER -
