A TQTc Study for Omaveloxolone

Inclusion criteria

• Healthy adult males and/or females, 18 to 55 years of age (inclusive) at the time of screening.
• BMI at screening between 18.0 and 32.0 kg/m2 (inclusive)
• Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
• Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Exclusion criteria

• History of clinically significant drug allergies, including allergies to any of the components of the study drugs (omaveloxolone and moxifloxacin) and/or clinically significant food allergies as determined by the investigator.
• Subject has an ECG abnormality, including corrected QT interval (QTc)> 450 msec for males, and > 460 msec for females, HR < 45 bpm or > 100 bpm after 5 minutes in supine position, PR interval > 220 msec, or QRS interval > 110 msec.
• Subject has allergy to band aids, adhesive dressing, or medical tape.
• Subject has hypotension (systolic blood pressure blood pressure [BP] ≤ 90 mmHg, diastolic BP ≤ 50 mmHg), or hypertension (systolic BP ≥ 140 mmHg, diastolic BP ≥ 90 mmHg) at screening.
• Subject has history of prolonged QTc, cardiac arrhythmia, or first-degree relatives with congenital Long QT syndrome or unexplained sudden death in young age.
• Subject has a history of unstable angina, syncope, coronary artery disease, myocardial infarction, congestive heart failure (CHF), transient ischemic attack (TIA), or neurological disorder.
• Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease, as determined by the investigator.
• Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
• Requirement for any over the counter and/or prescription medication, vitamins, and/or herbal supplements on a regular basis
• Use of any medications (over the counter and/or prescription medication), vitamins, and/or herbal supplements, within the 14-days prior to study drug administration or within 5 halflives (if known), whichever is longer
• History of drug or alcohol abuse in the last 6 months as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition.
• Positive test result for drugs of abuse, alcohol, or cotinine at screening or Day -1.
• Positive test result for hepatitis B surface antigen, hepatitis C virus antibodies, or HIV antibodies at screening.
• Positive test result for COVID-19 at Day -1.
• Blood donation (excluding plasma donation) of approximately 500 mL within 56 days before screening or plasma donation within 7 days before screening.
• Receipt of any investigational product within a time period equal to 10 half-lives of the product, if known, or a minimum of 30 days before study drug administration.
• Consumption of alcohol within 72 hours before study drug administration.
• Consumption of grapefruit, grapefruit products, star fruit, star fruit products, Seville oranges, or Seville orange products within the 72-hour period before study drug administration.
• Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.
• Current enrollment in another clinical study.
• Previous enrollment in any clinical study involving omaveloxolone.