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

Overview

Journal Antimicrob Agents Chemother

Publisher American Society for Microbiology

Specialty Pharmacology

Date 2016 Feb 18

PMID 26883693

Citations 8

Authors

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

Affiliations

Soon will be listed here.

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.).

Citing Articles

Leveraging Physiologically Based Pharmacokinetic Modeling and Experimental Data to Guide Dosing Modification of CYP3A-Mediated Drug-Drug Interactions in the Pediatric Population.

Salerno S, Carreno F, Edginton A, Cohen-Wolkowiez M, Gonzalez D Drug Metab Dispos. 2021; 49(9):844-855.

PMID: 34154994 PMC: 10441624. DOI: 10.1124/dmd.120.000318.

A Dried Blood Spot Analysis for Solithromycin in Adolescents, Children, and Infants: A Short Communication.

Beechinor R, Cohen-Wolkowiez M, Jasion T, Hornik C, Lang J, Hernandez R Ther Drug Monit. 2019; 41(6):761-765.

PMID: 31318840 PMC: 6856424. DOI: 10.1097/FTD.0000000000000670.

Population Pharmacokinetics and Safety of Solithromycin following Intravenous and Oral Administration in Infants, Children, and Adolescents.

Gonzalez D, James L, Al-Uzri A, Bosheva M, Adler-Shohet F, Mendley S Antimicrob Agents Chemother. 2018; 62(8).

PMID: 29891609 PMC: 6105834. DOI: 10.1128/AAC.00692-18.

Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates.

Le J, Poindexter B, Sullivan J, Laughon M, Delmore P, Blackford M Ther Drug Monit. 2017; 40(1):103-108.

PMID: 29271816 PMC: 5764797. DOI: 10.1097/FTD.0000000000000466.

Spotlight on solithromycin in the treatment of community-acquired bacterial pneumonia: design, development, and potential place in therapy.

Donald B, Surani S, Deol H, Mbadugha U, Udeani G Drug Des Devel Ther. 2017; 11:3559-3566.

PMID: 29263651 PMC: 5732564. DOI: 10.2147/DDDT.S119545.

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