Clinical Trials

Inclusion Criteria:

• Providing informed consent, documented by signing and dating the currently valid informed consent form.
• Considered by the Investigator to have unimpaired consent capacity, without reliance on a legally authorized representative.
• Stated willingness and ability to comply with study procedures and availability for the duration of the study.
• ≥ 18 and ≤ 80 years of age.
• NTM infection meeting current ATS DSA Pulmonary NTM guidelines for systemic (IV) aminoglycoside therapy.
• Anticipated duration of IV amikacin treatment of at least 30 days at time of study entry.
• Statement of ability to take oral medication and adhere to the daily dosing regimen.
• For females of reproductive potential: If they are of childbearing potential, they must agree to practice an effective method of contraception (see Section 12.7) from the signing of the informed consent form until 1 month following discontinuation of study drug treatment or agree to practice true abstinence, when this is consistent with the preferred and usual lifestyle of the subject.  Understanding that rifampin or rifabutin antibiotic treatment might be necessary for treatment of NTM and that these medications can decrease effectiveness of hormonal methods of contraception, the patient using a hormonal method also agrees in such circumstance to use the effective combination of two non-hormonal contraceptive methods condoms for male partner, IUD or diaphragm with contraceptive gel for patient.
• For males of reproductive potential: Agree to practice effective barrier contraception (see Section (12.7)) from the signing of the informed consent form until 3 months (one spermatogenesis cycle) following the last dose of study drug, or agree to practice true abstinence.

Exclusion Criteria:

• Received a systemic aminoglycoside antibiotic within 90 days prior to planned first dose of amikacin.
• ECG at Screening or predose (mean of triplicate values) with QTcF interval > 450 msec for males and > 470 msec for females.
• ECG at Screening or predose with abnormalities that, in the Investigator’s judgment, might predispose patient to clinically significant arrhythmia.
• Patients taking clofazimine or bedaquiline AND who also have congestive heart failure, significant ventricular arrhythmia, uncorrected hypokalemia, or ECG (single at Screening, mean of triplicate at predose) showing QRS > 120 msec or heart rate < 50 bpm.
• Progressive liver disease (Child-Pugh B or C) which would affect or invalidate interpretation of change from the baseline liver function tests over the course of the study.
• Signs of disturbed integrity of the tympanic membrane, determined by otoscopy or tympanometry, including chronic perforation or middle ear or ear canal inflammation or effusion.
• History of congenital hearing loss, otological surgery (excluding myringotomy tubes or simple tympanoplasty healed and currently intact), sudden hearing loss, or Meniere’s disease.
• Bilateral profound hearing loss across the audiometric testing range.
• History of active malignancy, either untreated or under active treatment.
• Venous access not adequate for performance of study procedures.
• 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.
• Current or anticipated use of excluded concomitant medications as specified in Section 6.5.
• Pregnant or lactating.
• Female of childbearing potential does not have a negative serum pregnancy test.
• Female relying on menopausal status for contraception does not have FSH level consistent with that condition.
• Currently under correctional supervision (imprisoned, on probation or parole).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/20/23. Questions regarding updates should be directed to the study team contact.