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

Study Overview
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Brief Summary
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To Evaluate the Bioequivalence of the two formulations of IPI-145 and the Effect of Food on the Pharmacokinetics of IPI-145

Detailed Description
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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.

Official Title
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A Phase 1, Open-label, 2-Part Study to Evaluate the Bioequivalence of the Duvelisib Marker-Image Formulation to the Duvelisib Clinical-Trial Formulation and to Assess the Effect of Food on the Pharmacokinetics of IP Duvelisib in Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: IPI-145 (duvelisib)
* Drug: IPI-145
* Drug: IPI-145


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1 Cohort 1<br>IPI-145 test formulation (capsule) high single dose and IPI-145 reference formulation (capsule) high single dose | Drug: IPI-145 (duvelisib)<br>* High single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) high single oral dose<br>|
| Experimental: Part 1 Cohort 2<br>IPI-145 test formulation (capsule) low single dose and IPI-145 reference formulation (capsule) low single dose | Drug: IPI-145<br>* Low single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) low single oral dose<br>|
| Experimental: Part 2 Cohort 3<br>IPI-145 test formulation (capsule) high single dose administered under fasted and fed conditions | Drug: IPI-145<br>* High single oral dose IPI-145 test formulation (capsule) with a high-fat meal and without food<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events following administration of IPI-145 |  | 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Pharmacokinetics, Food, Healthy Adult, Phase 1