Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis

Phase 1 Completed 37 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this trial is to determine the pediatric dose of delamanid that is equivalent to the adult dose already shown to be effective against multidrug-resistant tuberculosis.

Timeline

Start: 2013-06-14
Primary completion: 2017-12-10
Completion: 2017-12-28

Publications

Garcia-Prats AJ, Frias M, van der Laan L, De Leon A, Gler MT, Schaaf HS, Hesseling AC, Malikaarjun S, Hafkin J. Delamanid Added to an Optimized Background Regimen in Children with Multidrug-Resistant Tuberculosis: Results of a Phase I/II Clinical Trial. Antimicrob Agents Chemother. 2022 May 17;66(5):e0214421. doi: 10.1128/aac.02144-21. Epub 2022 Apr 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Delamanid	Small molecule	5 mg	—
Subject	Delamanid	Small molecule	10 mg	—
Subject	Delamanid	Small molecule	25 mg	—
Subject	Delamanid	Small molecule	50 mg	—
Subject	Delamanid	Small molecule	100 mg	—

Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis

Summary

Timeline

Publications

Drugs

Indications