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

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ClinicalTrials.gov Identifier: NCT02307461
Recruitment Status : Completed
First Posted : December 4, 2014
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Verastem, Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: IPI-145 (duvelisib) Drug: IPI-145 Phase 1

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : November 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
Experimental: Part 1 Cohort 1
IPI-145 test formulation (capsule) high single dose and IPI-145 reference formulation (capsule) high single dose
Drug: IPI-145 (duvelisib)
High single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) high single oral dose

Experimental: Part 1 Cohort 2
IPI-145 test formulation (capsule) low single dose and IPI-145 reference formulation (capsule) low single dose
Drug: IPI-145
Low single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) low single oral dose

Experimental: Part 2 Cohort 3
IPI-145 test formulation (capsule) high single dose administered under fasted and fed conditions
Drug: IPI-145
High single oral dose IPI-145 test formulation (capsule) with a high-fat meal and without food




Primary Outcome Measures :
  1. Assessment of bioequivalence of the IPI-145 test and reference formulations [ Time Frame: 24 Hours ]
  2. Pharmacokinetic Parameter (AUClast ) of IPI-145 [ Time Frame: Over 24 hours ]
  3. Pharmacokinetic Parameter (AUCinf ) of IPI-145 [ Time Frame: Over 24 hours ]
  4. Pharmacokinetic Parameter (Cmax) of IPI-145 [ Time Frame: Over 24 hours ]

Secondary Outcome Measures :
  1. Incidence of adverse events following administration of IPI-145 [ Time Frame: 7 weeks ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307461


Locations
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United States, Kansas
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Verastem, Inc.
Investigators
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Principal Investigator: Daniel Dickerson, MD, PhD PRA International, Inc
Study Chair: Hagop Youssoufian, MD Verastem, Inc.

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Responsible Party: Verastem, Inc.
ClinicalTrials.gov Identifier: NCT02307461     History of Changes
Other Study ID Numbers: IPI-145-15
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: July 2017
Keywords provided by Verastem, Inc.:
Phase 1
Bioequivalence
Pharmacokinetics
Food
Healthy Adult