Duvelisib in Hepatically Impaired Subjects Compared to Healthy Subjects

Hepatic Impairment Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02095587
• Other study ID #: IPI-145-14
• Status: Completed
• Phase: Phase 1
• Start date: March 2014
• Est. completion date: October 2014

Study information

• Verified date: March 2021
• Source: SecuraBio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the pharmacokinetics, safety, and tolerability of IPI-145 when administered to subjects with chronic hepatic impairment and in matched healthy subjects.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• IPI-145
25 mg single oral capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SecuraBio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of adverse events following administration of IPI-145	Safety Findings	10 days