Developing ORC-13661 for Preventing Aminoglycoside Antibiotics-induced Hearing Loss

开发 ORC-13661 用于预防氨基糖苷类抗生素引起的听力损失

• 批准号: 10910769
• 负责人: Tracey Rogers
• 金额: $ 120.25万
• 依托单位: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10910769
• 关键词: Adverse effects; Aerobic; Affect; Amikacin; Aminoglycoside Antibiotics; Antibiotic Therapy; Antibiotics; Auditory; Cessation of life; Chemistry; Data; Disease; Dizziness; Drug Interactions; Equilibrium; Excipients; Formulation; Hair Cells; Impairment; Infection; Labyrinth; Natural Killer Cells; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Phase II Clinical Trials; Safety; System; Therapeutic; United States Food and Drug Administration; Validation; analytical method; capsule; healthy volunteer; hearing impairment; manufacture; mycobacterial; ototoxicity; phase I trial; phase II trial; pre-clinical; prevent; side effect; small molecule

To support the planned Phase II clinical trial, key Chemistry, Manufacturing and Controls activities were completed, including analytical method validation, excipient studies, and manufacturing of drug product as a capsule form. A PK study to compare the new formulation (active pharmaceutical ingredient (API) + excipient in capsule) with the previous formulation (API only in capsule) is currently ongoing. The DDI study with the AG antibiotic, amikacin, was completed to fulfill a request from the Food and Drug Administration (FDA).

为了支持计划的 II 期临床试验，完成了关键的化学、制造和控制活动，包括分析方法验证、赋形剂研究和胶囊形式药品的制造。目前正在进行一项 PK 研究，以比较新配方（活性药物成分 (API) + 胶囊中的赋形剂）与之前的配方（仅胶囊中的 API）。针对 AG 抗生素阿米卡星的 DDI 研究是为了满足美国食品和药物管理局 (FDA) 的要求而完成的。