Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2016 Mar 25;60(4):2572-6.
doi: 10.1128/AAC.02561-15. Print 2016 Apr.

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

Daniel Gonzalez  1 , Debra L Palazzi  2 , Leena Bhattacharya-Mithal  3 , Amira Al-Uzri  4 , Laura P James  5 , John Bradley  6 , Natalie Neu  7 , Theresa Jasion  8 , Christoph P Hornik  9 , P Brian Smith  9 , Daniel K Benjamin Jr  9 , Kara Keedy  10 , Prabhavathi Fernandes  10 , Michael Cohen-Wolkowiez  11
Affiliations
Clinical Trial

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

Daniel Gonzalez et al. Antimicrob Agents Chemother. .

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.).

PubMed Disclaimer

Figures

FIG 1
FIG 1
Solithromycin plasma concentration versus time after dose in adolescents. Each line denotes an individual subject concentration versus time curve.
FIG 2
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.
See this image and copyright information in PMC

References

    1. US Centers for Disease Control and Prevention. 2013. Antibiotic resistance threats in the United States, 2013. http://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013... Accessed 19 October, 2015.
    1. Gonzalez D, Melloni C, Poindexter BB, Yogev R, Atz AM, Sullivan JE, Mendley SR, Delmore P, Delinsky A, Zimmerman K, Lewandowski A, Harper B, Lewis KC, Benjamin DK Jr, Cohen-Wokowiez M, Best Pharmaceuticals for Children Act—Pediatric Trials Network Administrative Core Committee. 2015. Simultaneous determination of trimethoprim and sulfamethoxazole in dried plasma and urine spots. Bioanalysis 7:1137–1149. doi:10.4155/bio.15.38. - DOI - PMC - PubMed
    1. Parsons TL, Marzinke MA, Hoang T, Bliven-Sizemore E, Weiner M, Mac Kenzie WR, Dorman SE, Dooley KE. 2014. Quantification of rifapentine, a potent anti-tuberculosis drug, from dried blood spot samples using liquid chromatographic-tandem mass spectrometric analysis. Antimicrob Agents Chemother 58:6747–6757. doi:10.1128/AAC.03607-14. - DOI - PMC - PubMed
    1. Ting LS, Villeneuve E, Ensom MH. 2006. Beyond cyclosporine: a systematic review of limited sampling strategies for other immunosuppressants. Ther Drug Monit 28:419–430. doi:10.1097/01.ftd.0000211810.19935.44. - DOI - PubMed
    1. Still JG, Schranz J, Degenhardt TP, Scott D, Fernandes P, Gutierrez MJ, Clark K. 2011. Pharmacokinetics of solithromycin (CEM-101) after single or multiple oral doses and effects of food on single-dose bioavailability in healthy adult subjects. Antimicrob Agents Chemother 55:1997–2003. doi:10.1128/AAC.01429-10. - DOI - PMC - PubMed

Publication types

Associated data