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

March 15, 2021 updated by: SecuraBio

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of bioequivalence of the IPI-145 test and reference formulations
Time Frame: 24 Hours
24 Hours
Pharmacokinetic Parameter (AUClast ) of IPI-145
Time Frame: Over 24 hours
Over 24 hours
Pharmacokinetic Parameter (AUCinf ) of IPI-145
Time Frame: Over 24 hours
Over 24 hours
Pharmacokinetic Parameter (Cmax) of IPI-145
Time Frame: Over 24 hours
Over 24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SecuraBio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IPI-145-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on IPI-145 (duvelisib)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe