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

NCT02307461 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2021-03-17

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

IPI-145 (duvelisib)

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

DRUG

IPI-145

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

DRUG

IPI-145

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

Sponsors & Collaborators

  • SecuraBio

    lead INDUSTRY

Principal Investigators

  • Hagop Youssoufian, MD · Verastem, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-08-31
Completion
2015-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02307461 on ClinicalTrials.gov