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

National Center For Advancing Translational Sciences

Investigators

Abstract

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).