Bioequivalence of Duvelisib and Food Effect on Pharmacokinetics of IPI-145
NCT ID: NCT02307461
Last Updated: 2021-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
103 participants
INTERVENTIONAL
2014-11-30
2015-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Part 1 Cohort 1
IPI-145 test formulation (capsule) high single dose and IPI-145 reference formulation (capsule) high single dose
IPI-145 (duvelisib)
High single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) high single oral dose
Part 1 Cohort 2
IPI-145 test formulation (capsule) low single dose and IPI-145 reference formulation (capsule) low single dose
IPI-145
Low single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) low single oral dose
Part 2 Cohort 3
IPI-145 test formulation (capsule) high single dose administered under fasted and fed conditions
IPI-145
High single oral dose IPI-145 test formulation (capsule) with a high-fat meal and without food
Interventions
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IPI-145 (duvelisib)
High single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) high single oral dose
IPI-145
Low single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) low single oral dose
IPI-145
High single oral dose IPI-145 test formulation (capsule) with a high-fat meal and without food
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
Yes
Sponsors
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SecuraBio
INDUSTRY
Responsible Party
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Principal Investigators
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Hagop Youssoufian, MD
Role: STUDY_CHAIR
Verastem, Inc.
Locations
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Lenexa, Kansas, United States
Countries
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Other Identifiers
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IPI-145-15
Identifier Type: -
Identifier Source: org_study_id
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