A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers

Inclusion Criteria:

- Male or female and age is between 18 and 55 years, inclusive;

- All female subjects must have negative results for pregnancy tests performed;

- If male, subject must be surgically sterile or practicing at least 1 of the following
methods of contraception, from initial study drug administration through 90 days after
administration of the last dose of study drug;

- If male, subject agrees to abstain from sperm donation through 90 days after
administration of the last dose of study drug;

- Body Mass Index (BMI) is ≥ 18 to ≤ 31 kg/m2, inclusive;

- A condition of general good health, based upon the results of a medical history,
physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram
(ECG), as judged by the investigator.

Exclusion Criteria:

- 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;

- Recent (6-month) history of drug or alcohol abuse;

- 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 prior to study drug administration;

- Positive screen results for drugs of abuse, alcohol, or cotinine at screening or Day
-1;

- Consumption of alcohol within 72 hours prior to study drug administration;

- Consumption of grapefruit, grapefruit products, star fruit, star fruit products, or
Seville oranges within the 72-hour period prior to study drug administration;

- Use of tobacco or nicotine-containing products within the 6-month period preceding
study drug administration;

- 17.10. Current enrollment in another clinical study.