Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
ID05730283

Phase 2 Study of ORC-13661 to Prevent Hearing Loss in Patients Receiving IV Amikacin for Nontuberculous Mycobacterium Disease

Led by Kevin Winthrop · Updated on 2026-05-07

105

Participants Needed

7

Research Sites

N/A

Total Duration

On this page

Sponsors

K

Kevin Winthrop

Lead Sponsor

N

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the effectiveness of the study drug ORC-13661 in preventing or reducing hearing loss caused by intravenous amikacin treatment in patients with nontuberculous mycobacteria (NTM) infection. NTM can cause serious lung disease, mostly affecting older adults, and amikacin, a common treatment, may damage inner ear cells leading to hearing and balance problems. This Phase 2 clinical trial compares different doses of ORC-13661 to a placebo to determine its potential to protect hearing during amikacin therapy. Participants will be divided randomly into three groups: one receiving a high dose of ORC-13661 starting with a 150mg loading dose then 30mg daily, another receiving a low dose with a 60mg loading dose then 12mg daily, and a third receiving a placebo. All study drugs are taken daily alongside intravenous amikacin for up to 90 days or until the amikacin treatment ends, whichever comes first. This double-blind, placebo-controlled design helps assess how well each dose prevents hearing loss. During the study, participants will take the study drug while undergoing amikacin treatment. Researchers will monitor hearing function and balance through clinical evaluations. The main measurement is prevention or reduction of hearing damage from the start of treatment through 28 days after stopping study treatment or after 90 days on study drug. Additional assessments will track speech perception, auditory and balance effects, and quality of hearing. Overall, participants are observed throughout the treatment period to determine the safety and impact of ORC-13661 on ototoxicity.

CONDITIONS

Brief Title

Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide informed consent by signing the consent form.
  • Have the ability to understand and consent without a legal representative.
  • Willing and able to follow study procedures and be available for the study duration.
  • Aged over 18 and under 80 years old.
  • Diagnosed with NTM infection meeting pulmonary guidelines requiring IV aminoglycoside therapy.
  • Expected to receive IV amikacin treatment for at least 30 days at study entry.
  • Able to take oral medication daily and follow dosing instructions.
  • Females of childbearing potential must agree to use effective double barrier contraception or true abstinence during the study and for 1 month after.
  • Males of reproductive potential must agree to use effective barrier contraception or true abstinence during the study and for 3 months after.
Not Eligible

You will not qualify if you...

  • Received systemic aminoglycoside antibiotics within 6 months before first amikacin dose.
  • ECG with QTcF interval 450 msec or greater at screening or before randomization.
  • ECG abnormalities that increase risk of serious arrhythmia.
  • Use of strong CYP3A4 inducers or inhibitors within 7 days prior to randomization or planned during study.
  • Use of clofazimine or bedaquiline with heart failure, arrhythmia, low potassium, or certain ECG changes.
  • Prior amikacin exposure within 6 months before randomization.
  • Known amikacin resistance with MIC over 64.
  • Progressive liver disease affecting liver function tests.
  • Ear conditions such as tympanic membrane perforation or inflammation.
  • History of congenital hearing loss, ear surgery (except minor healed procedures), sudden hearing loss, or Meniere's disease.
  • Severe bilateral hearing loss over 90 dB HL.
  • Conductive hearing loss with air-bone gaps over 15 dB HL.
  • Active or untreated malignancy.
  • Risk factors for Torsades des Pointes like heart failure or family history.
  • Inadequate venous access for study procedures.
  • Any condition or finding judged by investigator to pose unreasonable risk or interfere with study.
  • Use of excluded medications as specified.
  • Pregnancy or lactation.
  • Females of childbearing potential without negative pregnancy test or contraception agreement.
  • Females relying on menopausal status without confirming hormone levels and contraception agreement.
  • Currently under correctional supervision such as imprisonment, probation, or parole.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 90 days or until IV amikacin treatment ends

Participants take the study drug or placebo daily during their IV amikacin treatment to prevent hearing loss. Treatment lasts up to 90 days or until amikacin treatment ends, whichever is sooner.

Daily medication intake during treatment period

Follow-up

Duration - Approximately 28 days after treatment ends

Participants are monitored for hearing and balance effects after completing treatment to assess prevention of ototoxicity.

1 to 2 visits within 28 days after treatment completion

Trial Site Locations

Total: 7 locations

1

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

2

National Jewish Health

Denver, Colorado, United States, 80206

Actively Recruiting

3

Johns Hopkins University

Baltimore, Maryland, United States, 21224

Not Yet Recruiting

4

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

5

Oregon Health & Science University

Portland, Oregon, United States, 97239

Actively Recruiting

6

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

7

University of Texas Health Science Center

Tyler, Texas, United States, 75708

Actively Recruiting

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Research Team

D

Daniel Bouchat

A

Alyssa Schroeder

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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Published Research Related To This Trial

Phenotypic Optimization of Urea-Thiophene Carboxamides To Yield Potent, Well Tolerated, and Orally Active Protective Agents against Aminoglycoside-Induced Hearing Loss.

Sarwat Chowdhury, Kelly N Owens, R Jason Herr...

https://pubmed.ncbi.nlm.nih.gov/28992413

Prospective cohort study of ototoxicity in persons with cystic fibrosis following a single course of intravenous tobramycin.

Angela Garinis, Malcolm Gleser, Alexis Johns...

https://pubmed.ncbi.nlm.nih.gov/32713806

Priorities for hearing loss prevention and estimates of global cause-specific burdens of hearing loss: a systematic rapid review.

Kavita Prasad, Ethan D Borre, Lauren K Dillard...

https://pubmed.ncbi.nlm.nih.gov/38245112