Duvelisib in Hepatically Impaired Subjects Compared to Healthy Subjects

NCT ID: NCT02095587

Last Updated: 2021-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-10-31

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.

Conditions

Hepatic Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Mild Hepatic Impairment

Group Type: EXPERIMENTAL

IPI-145

Intervention Type: DRUG

25 mg single oral capsule

Moderate Hepatic Impairment

Group Type: EXPERIMENTAL

IPI-145

Intervention Type: DRUG

25 mg single oral capsule

Healthy Subjects

Group Type: EXPERIMENTAL

IPI-145

Intervention Type: DRUG

25 mg single oral capsule

Severe Hepatic Impairment

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

Group Type: EXPERIMENTAL

IPI-145

Intervention Type: DRUG

25 mg single oral capsule

Interventions

IPI-145

25 mg single oral capsule

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SecuraBio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hagop Youssoufian, MD

Role: STUDY_CHAIR

Verastem, Inc.

Locations

Miami, Florida, United States

Countries

United States

Other Identifiers

IPI-145-14

Identifier Type: -

Identifier Source: org_study_id