Duvelisib in Hepatically Impaired Subjects Compared to Healthy Subjects

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Infinity Pharmaceuticals, Inc.; SecuraBio

Criteria

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