To Evaluate the Bioequivalence of the two formulations of IPI-145 and the Effect of Food on the Pharmacokinetics of IPI-145

This Phase 1, randomized, open-label study of IPI-145 will be conducted in 2 parts.

Part 1 will be conducted in 2 cohorts. Cohort 1 will consist of 32 healthy subjects, and Cohort 2 will consist of 52 healthy subjects. Subjects in each cohort will receive 2 doses of IPI under fasted conditions in a 2-period, 2-sequence crossover design. Dosing in Period 1 and Period 2 will be separated by at least 7 days.

Part 2 is a 2-period, 2-sequence crossover design to assess the effect of a high-fat meal on the PK of the IPI-145 in 20 subjects. Subjects will receive single oral doses under fed (high-fat meal) and fasted conditions, separated by at least 7 days.

Inclusion Criteria:

• Men or women of non-child bearing potential between 18-50 years of age
• Body Mass Index (BMI): 18.0 - 32.0 kg/m2.
• Healthy subjects: in good health, determined by no clinically significant findings from clinical evaluations
• Provided written informed consent prior to any study specific procedures

Exclusion Criteria:

• Women of childbearing potential
• Healthy subjects: positive screening test for hepatitis B surface antigen, hepatitis C antibody, or HIV-1/HIV-2 antibodies
• ECG at screening showing QTcF ≥ 450 msec
• Evidence of clinically significant medical conditions
• History of gastrointestinal disease or surgery that may affect drug absorption
• Positive T-Spot (tuberculosis)TB test at screening
• Any active infection at the time of screening or admission