Bioequivalence of Duvelisib and Food Effect on Pharmacokinetics of IPI-145

Secura Bio

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: IPI-145 (duvelisib); Drug: IPI-145

Study type: Interventional

Funder types: Industry

Identifiers

NCT02307461

IPI-145-15

Details and patient eligibility

About

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

Full description

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.

Enrollment: 103 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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103 participants in 3 patient groups

Part 1 Cohort 1

Experimental group

Description:

IPI-145 test formulation (capsule) high single dose and IPI-145 reference formulation (capsule) high single dose

Treatment:

Drug: IPI-145 (duvelisib)

Part 1 Cohort 2

Experimental group

Description:

IPI-145 test formulation (capsule) low single dose and IPI-145 reference formulation (capsule) low single dose

Treatment:

Drug: IPI-145

Drug: IPI-145

Part 2 Cohort 3

Experimental group

Description:

IPI-145 test formulation (capsule) high single dose administered under fasted and fed conditions

Treatment:

Drug: IPI-145

Drug: IPI-145