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.

• IPI-145 (duvelisib) (Drug): High single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) high single oral dose
• IPI-145 (Drug): Low single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) low single oral dose
• IPI-145 (Drug): High single oral dose IPI-145 test formulation (capsule) with a high-fat meal and without food

Primary outcomes

• Assessment of bioequivalence of the IPI-145 test and reference formulations [24 Hours]
• Pharmacokinetic Parameter (AUClast ) of IPI-145 [Over 24 hours]
• Pharmacokinetic Parameter (AUCinf ) of IPI-145 [Over 24 hours]
• Pharmacokinetic Parameter (Cmax) of IPI-145 [Over 24 hours]

Secondary outcomes

• Incidence of adverse events following administration of IPI-145 [7 weeks]

Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers

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

• Hagop Youssoufian, MD, Study chair, Verastem, Inc.