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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
Sponsored by
SecuraBio
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Experimental

Experimental

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

First Posted
March 21, 2014
Last Updated
March 15, 2021
Sponsor
SecuraBio
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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
No

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
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

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Duvelisib in Hepatically Impaired Subjects Compared to Healthy Subjects

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