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

• Sponsor: SecuraBio (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02095587
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 4
• Duration (Months): 7
• Patients Per Site Per Month: 3.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Impairment	Drug: IPI-145	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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 Start Date: Mar 1, 2014
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mild Hepatic Impairment	Drug: IPI-145; 25 mg single oral capsule
Experimental: Moderate Hepatic Impairment	Drug: IPI-145; 25 mg single oral capsule
Experimental: Healthy Subjects	Drug: IPI-145; 25 mg single oral capsule
Experimental: Severe Hepatic Impairment Optional arm based on results from Arms 1, 2, and 3	Drug: IPI-145; 25 mg single oral capsule

Outcome Measures

Primary Outcome Measures

1. 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

1. Incidence of adverse events following administration of IPI-145 [10 days]

   Safety Findings

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Miami	Florida	United States	33014

Sponsors and Collaborators

• SecuraBio

Investigators

• Study Chair: Hagop Youssoufian, MD, Verastem, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SecuraBio
• ClinicalTrials.gov Identifier: NCT02095587
• Other Study ID Numbers: IPI-145-14
• First Posted: Mar 26, 2014
• Last Update Posted: Mar 17, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by SecuraBio: Phase 1; hepatic impairment
• Additional relevant MeSH terms: Liver Diseases

Study Results

No Results Posted as of Mar 17, 2021