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

Sponsor

SecuraBio (Industry)

Overall Status

Completed

CT.gov ID

NCT02307461

Collaborator

(none)

103

Enrollment

Location

Arms

Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

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 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.

Study Design

Study Type:

Interventional

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 :

Nov 1, 2014

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Incidence of adverse events following administration of IPI-145 [7 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Lenexa	Kansas	United States	66219

Sponsors and Collaborators

SecuraBio

Investigators

Study Chair: Hagop Youssoufian, MD, Verastem, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

SecuraBio

ClinicalTrials.gov Identifier:

NCT02307461

Other Study ID Numbers:

IPI-145-15

First Posted:

Dec 4, 2014

Last Update Posted:

Mar 17, 2021

Last Verified:

Mar 1, 2021

Keywords provided by SecuraBio

Study Results

No Results Posted as of Mar 17, 2021