Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin

Summary

The goal of this clinical trial is to test the effectiveness of the study drug, ORC-13361, in preventing hearing loss in patients with NTM infection who are undergoing treatment with IV amikacin therapy. The main question this study aims to answer is:

* Is ORC-13661 effective for preventing or lessening hearing loss induced by amikacin treatment?
* Is ORC-13661 effective for preventing or lessening other measures of hearing impairment?

Participants will be asked to take a study drug while they are being treated with IV amikacin. Participants will take study drug for 90 days or until the end of their amikacin treatment, whichever comes first. During this time, researchers will gather clinical data on the participants' health.

Researchers will compare three groups - two groups taking different doses of the study drug and one group taking a placebo drug - to see if dose of drug has any effect on preventing hearing loss. A placebo is a look-alike substance that contains no active drug.

Conditions

• Ototoxicity, Drug-Induced

Interventions

DRUG

ORC-13661

High-dose intervention (30mg daily)

DRUG

ORC-13661

Low-dose intervention (12mg daily)

DRUG

Placebo

Placebo intervention

Sponsors & Collaborators

• National Institute on Deafness and Other Communication Disorders (NIDCD)

  collaborator NIH

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• Oricula Therapeutics

  collaborator UNKNOWN

• University of Washington

  collaborator OTHER

• National Jewish Health

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• The University of Texas Health Science Center at Tyler

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Kevin Winthrop

  lead OTHER

Principal Investigators

• Kevin L Winthrop, MD, MPH · Oregon Health and Science University

• Edwin Rubel, PhD · Oricula Therapeutics

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-02

Primary Completion

2028-02-29

Completion

2028-02-29

FDA Drug

Yes

Countries

• United States

Study Locations