A Human AME Study for Omaveloxolone

Exclusion Criteria

• •Significant history or clinical manifestation of any major system disorder, as determined by the investigator (or designee).
• •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
• •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
• •Presence of any other condition, including surgery, known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
• •Abnormal laboratory values considered clinically significant by the investigator.
• •Clinically significant abnormal 12-lead ECGs.
• •History of alcoholism or drug/chemical abuse within 2 years prior to Check-in (Day-1).
• •Alcohol consumption of \> 21 units per week.
• •Positive urine drug screen at Screening, or positive alcohol breath test result or positive urine drug screen at Check-in (Day -1).
• •Positive hepatitis panel and/or positive human immunodeficiency virus test.
• •Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known) prior to dosing.
• •Current enrollment in another clinical study.