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

SecuraBio103 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

103

Conditions

Healthy

Interventions

IPI-145 (duvelisib)DRUG

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

IPI-145DRUG

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

IPI-145DRUG

High single oral dose IPI-145 test formulation (capsule) with a high-fat meal and without food

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Lenexa, Kansas, United States

Outcomes

Primary Outcomes

Assessment of bioequivalence of the IPI-145 test and reference formulations

Time frame: 24 Hours

Pharmacokinetic Parameter (AUClast ) of IPI-145

Time frame: Over 24 hours

Pharmacokinetic Parameter (AUCinf ) of IPI-145

Time frame: Over 24 hours

Pharmacokinetic Parameter (Cmax) of IPI-145

Time frame: Over 24 hours

Secondary Outcomes

Incidence of adverse events following administration of IPI-145

Time frame: 7 weeks

Data from ClinicalTrials.gov

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