Phase 2 Study of the Efficacy and Safety of ORC-13661 for the Prevention of Ototoxicity in Patients Receiving Intravenous Amikacin for Treatment of Non-Tuberculous Mycobacterium Infection
ORC-13661预防静脉阿米卡星治疗非结核分枝杆菌感染患者耳毒性的有效性和安全性的2期研究
基本信息
- 批准号:10426862
- 负责人:
- 金额:$ 65.79万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-09-19 至 2027-07-31
- 项目状态:未结题
- 来源:
- 关键词:AdultAdverse eventAftercareAirAmikacinAminoglycoside AntibioticsAminoglycosidesAnimal ModelAntibiotic TherapyAntibioticsAuditory ThresholdAzithromycinBronchiectasisCanis familiarisChemicalsChronicChronic DiseaseClarithromycinClinicalCochleaCommunicable DiseasesControl AnimalData ReportingDeteriorationDiagnosisDiseaseDisease ProgressionDoseDouble-Blind MethodDrug DesignDrug ExposureDrug KineticsElderlyElectrocardiogramEquilibriumEquipment and supply inventoriesEvaluationExposure toFDA approvedFrequenciesGenus MycobacteriumGoalsGram-Negative BacteriaGuidelinesHair CellsHalf-LifeHealthHearingHearing ProtectionHuman VolunteersIn VitroIntravenousLaboratoriesLaboratory FindingLegal patentLifeLungMeasurableMeasuresMetabolicMindMulti-Institutional Clinical TrialMusMycobacterium InfectionsNeonatalOralOral AdministrationOrgan of CortiPatientsPersonsPharmaceutical PreparationsPharmacotherapyPhasePlacebo ControlPlasmaPreventionPublishingQuality of lifeRandomizedRattusResearchRifampinSafetySensorineural Hearing LossSensory HairSerious Adverse EventSwimmingSymptomsTestingTherapeutic IndexTimeTinnitusToxic effectToxicologyTreatment ProtocolsUnited StatesUniversitiesVertigoWashingtonWomanWorkZebrafishaminoglycoside-induced ototoxicityawakebactericidebonechronic infectionclinically relevanteffective therapyeffectiveness evaluationefficacy evaluationefficacy studyexperimental studyhealthy volunteerhearing impairmentin vivoindexingmenneonatal micenon-tuberculosis mycobacterianovelnovel therapeuticsototoxicityovertreatmentphase 1 testingphase 2 studypre-clinicalpreventprevent hearing lossprimary endpointprogramsresponsesafety studysecondary endpointside effectsmall moleculespeech in noisetooltreatment duration
项目摘要
PROJECT SUMMARY
ORC-13661 is a new chemical entity being developed to prevent hearing loss in patients exposed to
aminoglycoside antibiotics (AGs). AGs are an important class of broad spectrum antibiotics especially
effective against gram-negative bacteria and Mycobacteria. Unfortunately, as many as 20% of patients
administered parenteral AGs for over 5 days suffer permanent, measurable hearing loss, as do upwards of
60% of patients on long term therapy. Largely because of the ototoxic side effects, AGs are currently
administered only for life threatening situations or where they are the only effective treatment. At this time
there are no FDA approved drugs that have been shown to prevent any form of sensorineural hearing loss.
Preventing AG-induced hearing loss would be of enormous benefit patients currently being treated with AGs. It
would also allow this inexpensive and effective but underused class of antibiotics to be used more routinely.
Oral ORC-13661was developed from a small molecule screen aimed finding a way to mitigate AG-induced hair
cell toxicity. It is robustly effective at preventing hearing loss in rats treated with prolonged high dose AGs.
ORC-13661 has completed nonclinical evaluation and Phase 1 testing in normal healthy volunteers.
Pulmonary and disseminated non-tuberculous Mycobacteria (NTM) infections are chronic infectious diseases
that develop progressively over time, and require prolonged parenteral AG therapy to achieve control or a cure.
Current guidelines recommend parenteral aminoglycoside (AG) therapy, usually a 90 day course of amikacin,
for patients with severe manifestations of the disease, particularly bronchiectasis.
We propose a randomized, double-blind, placebo-controlled, multicenter, phase 2 study of ORC-13661
administered orally in conjunction with intravenously administered amikacin to patients with severe NTM
infections. The goal of this to evaluate the efficacy of ORC-13661 for mitigation or prevention of ototoxicity.
Primary and secondary endpoints are changes in between baseline measures if hearing thresholds and
hearing in noise taken prior to drug treatment and after treatment is discontinued in groups of patients treated
with amikacin alone or with amikacin plus ORC-13661. Additional evaluations will changes in patient perceived
hearing and balance health and the safety and tolerability of ORC-13661 in patients with NTM as assessed by
AEs, clinical laboratory findings, vital signs, and electrocardiogram (ECG).
项目总结
项目成果
期刊论文数量(0)
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Edwin W Rubel其他文献
Edwin W Rubel的其他文献
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{{ truncateString('Edwin W Rubel', 18)}}的其他基金
Phase 2 Study of the Efficacy and Safety of ORC-13661 for the Prevention of Ototoxicity in Patients Receiving Intravenous Amikacin for Treatment of Non-Tuberculous Mycobacterium Infection
ORC-13661预防静脉阿米卡星治疗非结核分枝杆菌感染患者耳毒性的有效性和安全性的2期研究
- 批准号:
10706468 - 财政年份:2022
- 资助金额:
$ 65.79万 - 项目类别:
ROLE OF THE INNATE IMMUNE SYSTEM IN THE SURVIVAL OF AUDITORY NEURONS
先天免疫系统在听觉神经元生存中的作用
- 批准号:
10119786 - 财政年份:2017
- 资助金额:
$ 65.79万 - 项目类别:
Core Center--NIDCD Research Core Center P30
核心中心--NIDCD研究核心中心P30
- 批准号:
7901262 - 财政年份:2009
- 资助金额:
$ 65.79万 - 项目类别:
Core Center--NIDCD Research Core Center P30
核心中心--NIDCD研究核心中心P30
- 批准号:
6953304 - 财政年份:2000
- 资助金额:
$ 65.79万 - 项目类别:
Core Center - NIDCD Research Core Center P30
核心中心 - NIDCD 研究核心中心 P30
- 批准号:
8526210 - 财政年份:2000
- 资助金额:
$ 65.79万 - 项目类别:
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