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