Duvelisib in Hepatically Impaired Subjects Compared to Healthy Subjects

NCT02095587 | Completed Phase 1

• 1 other identifier: IPI-145-14
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Impairment

Keywords

Phase 1; hepatic impairment

Outcome Measures

Primary Outcomes (1)

• 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

  Open 72 hours

Secondary Outcomes (1)

• Incidence of adverse events following administration of IPI-145

  10 days

Study Arms (4)

Mild Hepatic Impairment

EXPERIMENTAL

Drug: IPI-145

Moderate Hepatic Impairment

EXPERIMENTAL

Drug: IPI-145

Healthy Subjects

EXPERIMENTAL

Drug: IPI-145

Severe Hepatic Impairment

EXPERIMENTAL

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

Drug: IPI-145

Interventions

IPI-145 DRUG

25 mg single oral capsule

Healthy Subjects; Mild Hepatic Impairment; Moderate Hepatic Impairment; Severe Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SecuraBio: lead

Study Sites (1)

Unknown Facility

Miami, Florida, 33014, United States

Location

MeSH Terms

Interventions

duvelisib

Study Officials

• Hagop Youssoufian, MD

  Verastem, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: March 26, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

US (1)