Back to results

Duvelisib in Hepatically Impaired Subjects Compared to Healthy Subjects (IPI-145-14)

Primary Purpose

Hepatic Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

IPI-145

About this trial

This is an interventional basic science trial for Hepatic Impairment focused on measuring Phase 1, hepatic impairment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Men or women of nonchildbearing potential between 18-70 years of age
Body Mass Index (BMI): 18.0 - 38.0 kg/m2.
Healthy subjects: in good health, determined by no clinically significant findings from clinical evaluations
Hepatic impairment subjects: confirmed hepatic impairment >1 year with etiology of chronic alcoholism, chronic viral hepatitis (B or C), nonalcoholic steatohepatitis, autoimmune hepatitis, Wilson disease, alpha-1 antitrypsin deficiency, glycogen storage diseases, or galactosemia
Provided written informed consent prior to any study specific procedures

Exclusion Criteria:

Women of childbearing potential
Hepatic impairment subjects: fluctuating or rapidly deteriorating hepatic function, acute hepatitis, variceal bleeding within 8 weeks of screening, a history of pancreatitis within 8 weeks of screening, evidence of hepatic encephalopathy > Grade 1, current unstable hematologic condition, and/or creatinine clearance < 60 mL/min
Healthy subjects: positive screening test for hepatitis B surface antigen, or hepatitis C antibody
ECG at screening or Day -1 showing QTcF ≥ 450 msec for healthy subjects or > 500 msec for hepatically impaired subjects
Evidence of clinically significant medical conditions
History of gastrointestinal disease or surgery that may affect drug absorption
Positive or indeterminate QuantiFERON-TB Gold test at screening
Any active infection at the time of screening or admission

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Mild Hepatic Impairment

Moderate Hepatic Impairment

Healthy Subjects

Severe Hepatic Impairment

Arm Description

Optional arm based on results from Arms 1, 2, and 3

Outcomes

Primary Outcome Measures

Pharmacokinetic parameters of IPI-145 and its primary metabolite, IPI-656

PK parameters (AUC, Cmax and t1/2) of IPI-145 and its metabolite, IPI-656 Plasma concentrations of IPI-145 and its metabolite, IPI-656

Secondary Outcome Measures

Incidence of adverse events following administration of IPI-145

Safety Findings

Full Information

NCT ID

NCT02095587

First Posted

March 21, 2014

Last Updated

March 15, 2021

Sponsor

SecuraBio

1. Study Identification

Unique Protocol Identification Number

NCT02095587

Brief Title

Duvelisib in Hepatically Impaired Subjects Compared to Healthy Subjects

Acronym

IPI-145-14

Official Title

A Phase 1, Open-Label, Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Duvelisib in Subjects With Chronic Hepatic Impairment Compared to Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SecuraBio

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To evaluate the pharmacokinetics, safety, and tolerability of IPI-145 when administered to subjects with chronic hepatic impairment and in matched healthy subjects.

Detailed Description

This is a nonrandomized, open-label, parallel-group, single oral dose study in subjects with chronic hepatic impairment and matched (age, sex, weight, BMI) healthy subjects. Subjects will be enrolled into 1 of 3 groups based on hepatic impairment grade: mild, moderate and normal hepatic function. An optional severe hepatic impairment group will enroll based on data from the mild and moderate hepatic impairment groups in comparison to matched healthy group. All subjects will receive a single oral dose of IPI-145 25 mg.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Impairment

Keywords

Phase 1, hepatic impairment

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mild Hepatic Impairment

Arm Type

Experimental

Arm Title

Moderate Hepatic Impairment

Arm Type

Experimental

Arm Title

Healthy Subjects

Arm Type

Experimental

Arm Title

Severe Hepatic Impairment

Arm Type

Experimental

Arm Description

Optional arm based on results from Arms 1, 2, and 3

Intervention Type

Drug

Intervention Name(s)

IPI-145

Intervention Description

25 mg single oral capsule

Primary Outcome Measure Information:

Title

Pharmacokinetic parameters of IPI-145 and its primary metabolite, IPI-656

Description

PK parameters (AUC, Cmax and t1/2) of IPI-145 and its metabolite, IPI-656 Plasma concentrations of IPI-145 and its metabolite, IPI-656

Time Frame

Open 72 hours

Secondary Outcome Measure Information:

Title

Incidence of adverse events following administration of IPI-145

Description

Safety Findings

Time Frame

10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men or women of nonchildbearing potential between 18-70 years of age Body Mass Index (BMI): 18.0 - 38.0 kg/m2. Healthy subjects: in good health, determined by no clinically significant findings from clinical evaluations Hepatic impairment subjects: confirmed hepatic impairment >1 year with etiology of chronic alcoholism, chronic viral hepatitis (B or C), nonalcoholic steatohepatitis, autoimmune hepatitis, Wilson disease, alpha-1 antitrypsin deficiency, glycogen storage diseases, or galactosemia Provided written informed consent prior to any study specific procedures Exclusion Criteria: Women of childbearing potential Hepatic impairment subjects: fluctuating or rapidly deteriorating hepatic function, acute hepatitis, variceal bleeding within 8 weeks of screening, a history of pancreatitis within 8 weeks of screening, evidence of hepatic encephalopathy > Grade 1, current unstable hematologic condition, and/or creatinine clearance < 60 mL/min Healthy subjects: positive screening test for hepatitis B surface antigen, or hepatitis C antibody ECG at screening or Day -1 showing QTcF ≥ 450 msec for healthy subjects or > 500 msec for hepatically impaired subjects Evidence of clinically significant medical conditions History of gastrointestinal disease or surgery that may affect drug absorption Positive or indeterminate QuantiFERON-TB Gold test at screening Any active infection at the time of screening or admission

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hagop Youssoufian, MD

Organizational Affiliation

Verastem, Inc.

Official's Role

Study Chair

Facility Information:

City

Miami

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Duvelisib in Hepatically Impaired Subjects Compared to Healthy Subjects

We'll reach out to this number within 24 hrs