ORC-13661 for Preventing Ototoxicity

Recruiting at 4 trial locations

Overseen By Ted Warnock

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kevin Winthrop

Must be taking: IV amikacin

Must not be taking: CYP3A4 inducers, CYP3A4 inhibitors

Disqualifiers: Amikacin exposure, Congenital hearing loss, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12-13 weeks

105 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a drug called ORC-13661 to see if it can prevent hearing loss in older patients with a lung infection who are being treated with amikacin. The drug aims to protect the inner ear from damage caused by amikacin. Researchers will compare different doses of ORC-13661 to determine its effectiveness. ORC-13661 is a new drug derived from PROTO-1, which was first identified as protective in initial studies.

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but you cannot take certain drugs like strong CYP3A4 inducers or inhibitors during the study. It's best to discuss your current medications with the study team to see if any adjustments are needed.

How does the drug ORC-13661 prevent ototoxicity differently from other drugs?

ORC-13661 is unique because it is specifically designed to prevent ototoxicity, which is hearing damage caused by certain medications. Unlike other treatments that may not directly target this issue, ORC-13661 focuses on protecting the ear from damage, potentially offering a novel approach to preserving hearing in patients at risk. ^{1 2 3 4 5}

Research Team

Kevin L Winthrop, MD, MPH

Principal Investigator

Oregon Health and Science University

Edwin Rubel, PhD

Principal Investigator

Oricula Therapeutics

Eligibility Criteria

Adults aged 18-80 with NTM infection requiring IV amikacin treatment, who can take oral medication and follow the study's procedures. They must not have had amikacin in the last 6 months or known resistance to it. Participants need effective contraception if of reproductive potential and cannot be pregnant, lactating, or under correctional supervision.

Inclusion Criteria

I agree to use effective contraception or practice abstinence for 3 months after the last dose.

Providing informed consent, documented by signing and dating the currently valid informed consent form

I can make my own medical decisions without needing a legal guardian.

Exclusion Criteria

Presence of any circumstance, condition, ECG or laboratory finding that, based on investigator judgment, would interfere with study procedures or assessments or present to the patient an unreasonable risk from participation in this study

I am taking clofazimine or bedaquiline and have heart issues or low potassium.

Pregnant or lactating

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either high-dose ORC-13661, low-dose ORC-13661, or placebo concurrently with IV amikacin for up to 90 days

12-13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ORC-13661
• Placebo

Trial Overview The trial is testing ORC-13661's ability to prevent hearing loss from IV amikacin therapy in NTM patients. It compares two different doses of ORC-13661 against a placebo over at least 30 days. Researchers will monitor participants' hearing and overall health during this period.

Participant Groups

Group I: Low Dose ORC-13661 Experimental Treatment 1 Intervention

This arm is a daily treatment regimen of study drug (ORC-13661) with a loading dose of 60mg capsules followed by a daily dose of 12mg capsules. Treatment regimen will run concurrently with treatment with IV amikacin. Study drug treatment will continue until treatment with IV amikacin ends or 90 days, whichever is earlier.

Group II: High Dose ORC-13661 Experimental Treatment 1 Intervention

This arm is a daily treatment regimen of study drug (ORC-13661) with a loading dose of 150mg followed by a daily dose of 30mg. Treatment regimen will run concurrently with treatment with IV amikacin. Study drug treatment will continue until treatment with IV amikacin ends or 90 days, whichever is earlier.

Group III: Placebo Placebo Group 1 Intervention

This arm is a daily treatment regimen of a placebo with a loading dose and a daily dose of placebo capsules to match the treatment arms. Placebo regimen will run concurrently with treatment with IV amikacin. Placebo regimen will continue until treatment with IV amikacin ends or 90 days, whichever is earlier.

Who Is Running the Clinical Trial?

Kevin Winthrop

Lead Sponsor

Trials

4

Recruited

760+

Oricula Therapeutics

Collaborator

Trials

1

Recruited

110+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

National Jewish Health

Collaborator

Trials

145

Recruited

318,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

The University of Texas Health Science Center at Tyler

Collaborator

Trials

15

Recruited

25,700+

References

1. United States pubmed.ncbi.nlm.nih.gov

Ototoxicity: etiology and issues. [2005]

2. Germany pubmed.ncbi.nlm.nih.gov

Experimental, clinical and preventive aspects of ototoxicity. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Development of ebselen for the treatment of sensorineural hearing loss and tinnitus. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Drug-induced ototoxicity. Pathogenesis and prevention. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Intratympanic Administration of OTO-313 Reduces Tinnitus in Patients With Moderate to Severe, Persistent Tinnitus: A Phase 1/2 Study. [2023]