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

Secura Bio

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: IPI-145

Study type: Interventional

Funder types: Industry

Identifiers

NCT02095587

IPI-145-14

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 4 patient groups

Mild Hepatic Impairment

Experimental group

Treatment:

Drug: IPI-145

Moderate Hepatic Impairment

Experimental group

Treatment:

Drug: IPI-145

Healthy Subjects

Experimental group

Treatment:

Drug: IPI-145

Severe Hepatic Impairment

Experimental group

Description:

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

Treatment:

Drug: IPI-145