Biomarker-Assisted Dose Selection for Safety and Efficacy in Early Development of PNU-100480 for Tuberculosis
Wallis RS, Jakubiec W, Kumar V, Bedarida G, Silvia A, Paige D, Zhu T, Mitton-Fry M, Ladutko L, Campbell S, Miller PF. Biomarker-Assisted Dose Selection for Safety and Efficacy in Early Development of PNU-100480 for Tuberculosis. Antimicrobial Agents And Chemotherapy 2010, 55: 567-574. PMID: 21078950, PMCID: PMC3028776, DOI: 10.1128/aac.01179-10.Peer-Reviewed Original ResearchMeSH KeywordsAcetamidesAdolescentAdultAnimalsAntitubercular AgentsArea Under CurveDose-Response Relationship, DrugDrug Administration ScheduleHumansLinezolidMicrobial Sensitivity TestsMiddle AgedMycobacterium tuberculosisOxazolidinonesPyrazinamideRatsSerum Bactericidal TestTreatment OutcomeTuberculosisYoung AdultConceptsPNU-100480Whole-blood bactericidal activityMultiple ascending dosesDays of dosingSerious global health threatWhole blood culturesBactericidal activityGlobal health threatM. tuberculosis growthAscending dosesSixth cohortNew tuberculosis treatmentsPlasma drugTuberculosis treatmentPlasma concentrationsSafety signalsHealthy volunteersDose selectionRoutine safety testsNew treatmentsDay 27TuberculosisMycobacterium tuberculosisDosesHealth threat