Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin

Conditions

• Ototoxicity, Drug-Induced

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• ORC-13661 — DRUG
  High-dose intervention (30mg daily)
• ORC-13661 — DRUG
  Low-dose intervention (12mg daily)
• Placebo — DRUG
  Placebo intervention

Study Details

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.

Key Dates

Start date

Jun 2, 2025

Status verified

May 2026

Primary completion

Feb 29, 2028

Completion

Feb 29, 2028

Study Design

Enrollment

105 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: High Dose ORC-13661
  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.
• Experimental: Low Dose ORC-13661
  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.
• Placebo Comparator: Placebo
  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.

Primary Outcome Measure

Mitigation or Prevention of Ototoxicity [ Time Frame: Baseline to 28 (±5) days after study treatment discontinuation or 28 days after 90 days of study treatment, whichever comes first. ]

Central Contacts

• Daniel Bouchat
  503-494-2568
  [email protected]
• Alyssa Schroeder
  503-494-2136
  [email protected]

Locations (7)

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