Bioequivalence of Duvelisib and Food Effect on Pharmacokinetics of IPI-145
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
1 other identifier
interventional
103
1 country
1
Brief Summary
To Evaluate the Bioequivalence of the two formulations of IPI-145 and the Effect of Food on the Pharmacokinetics of IPI-145
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Nov 2014
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 18, 2014
CompletedFirst Posted
Study publicly available on registry
December 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedMarch 17, 2021
March 1, 2021
9 months
November 18, 2014
March 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (1)
Incidence of adverse events following administration of IPI-145
7 weeks
Study Arms (3)
Part 1 Cohort 1
EXPERIMENTALIPI-145 test formulation (capsule) high single dose and IPI-145 reference formulation (capsule) high single dose
Part 1 Cohort 2
EXPERIMENTALIPI-145 test formulation (capsule) low single dose and IPI-145 reference formulation (capsule) low single dose
Part 2 Cohort 3
EXPERIMENTALIPI-145 test formulation (capsule) high single dose administered under fasted and fed conditions
Interventions
High single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) high single oral dose
Low single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) low single oral dose
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SecuraBiolead
Study Sites (1)
Unknown Facility
Lenexa, Kansas, 66219, United States
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
Hagop Youssoufian, MD
Verastem, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2014
First Posted
December 4, 2014
Study Start
November 1, 2014
Primary Completion
August 1, 2015
Study Completion
September 1, 2015
Last Updated
March 17, 2021
Record last verified: 2021-03