drugset / Trial / NCT02268279
Pharmacokinetics and Safety of Solithromycin in Adolescents and Children
Phase 1
Completed
84 enrolled
Melinta Therapeutics, Inc.
Department of Health and Human Services · collab
NaSingle-groupOpen-labelTreatment
Summary
Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and intravenous) in children ages 0 to 17
Timeline
- Start
- 2015-01
- Primary completion
- 2016-10
- Completion
- 2016-10
Publications
- Beechinor RJ, Cohen-Wolkowiez M, Jasion T, Hornik CP, Lang JE, Hernandez R, Gonzalez D. A Dried Blood Spot Analysis for Solithromycin in Adolescents, Children, and Infants: A Short Communication. Ther Drug Monit. 2019 Dec;41(6):761-765. doi: 10.1097/FTD.0000000000000670.
- Gonzalez D, James LP, Al-Uzri A, Bosheva M, Adler-Shohet FC, Mendley SR, Bradley JS, Espinosa C, Tsonkova E, Moffett K, Marquez L, Simonsen KA, Stoilov S, Boakye-Agyeman F, Jasion T, Hornik CP, Hernandez R, Benjamin DK Jr, Cohen-Wolkowiez M. Population Pharmacokinetics and Safety of Solithromycin following Intravenous and Oral Administration in Infants, Children, and Adolescents. Antimicrob Agents Chemother. 2018 Jul 27;62(8):e00692-18. doi: 10.1128/AAC.00692-18. Print 2018 Aug.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Solithromycin | Other / unclassified | 6 mg/kg | Oral |
| Subject | Solithromycin | Other / unclassified | 8 mg/kg | Oral |
| Subject | Solithromycin | Other / unclassified | 15 mg/kg | Oral |