Bioequivalence of Duvelisib and Food Effect on 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