Duvelisib in Hepatically Impaired Subjects Compared to Healthy Subjects

Phase 1

Completed

• Conditions: Hepatic Impairment
• Interventions: Drug: IPI-145

• Registration Number: NCT02095587
• Lead Sponsor: SecuraBio

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-03-24
• Study First Posted: 2014-03-26
• Primary Completion: 2014-07
• Study Completion: 2014-10
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Severe Hepatic Impairment	IPI-145	Optional arm based on results from Arms 1, 2, and 3
Moderate Hepatic Impairment	IPI-145	-
Mild Hepatic Impairment	IPI-145	-
Healthy Subjects	IPI-145	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of IPI-145 and its primary metabolite, IPI-656	Open 72 hours	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

Name	Time	Method
Incidence of adverse events following administration of IPI-145	10 days	Safety Findings