ORC-13661 for Preventing Ototoxicity

Recruiting in Palo Alto (17 mi)

+4 other locations

Kevin Winthrop M.D., M.P.H. | Health ...

Overseen byEdwin Rubel, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Kevin Winthrop

Prior Safety Data

Breakthrough Therapy

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.

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.

+6 more

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

+19 more

Participant Groups

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.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Low Dose ORC-13661Experimental Treatment1 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-13661Experimental Treatment1 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: PlaceboPlacebo Group1 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.