Safety and Pharmacokinetics of AVL-292 Following Multiple Doses and the Effect of Food on the Single-dose Pharmacokinetics of AVL-292

Part 2 is an open-label, randomized, 2-period, 2-way crossover study to evaluate the effect
of a standard high-fat breakfast on the pharmacokinetics of AVL-292. Ten subjects will be
enrolled to receive 2 single doses of 200 mg AVL-292, one with food (i.e., fed) and the
other without (i.e., fasted), in a randomized sequence.

Inclusion Criteria:

- Healthy male or female subjects of any ethnic origin between ages of 18 and 65 with a
body mass index between 18 and 33

Exclusion Criteria:

- Recent history (i.e., within 3 years) of any clinically significant neurological,
gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine,
hematological, dermatological, psychological, ophthalmological, allergic or other
major disorders;

- Use of any prescribed systemic or topical medication within 30 days of the first
dose;

- Use of any non-prescribed systemic or topical medication (including vitamin/mineral
supplements and herbal medicines, e.g., St. John's Wort) within 7 days of the first
dose administration;

- Exposure to an investigational drug (new chemical entity) within 30 days prior to the
first dose administration