Duvelisib in Hepatically Impaired Subjects Compared to Healthy Subjects
Completed · Phase 1
Conditions studied: Hepatic Impairment
In brief
To evaluate the pharmacokinetics, safety, and tolerability of IPI-145 when administered to subjects with chronic hepatic impairment and in matched healthy subjects.
Key facts
- Study ID
- NCT02095587
- Run by
- SecuraBio
- People needed
- 24
- Starts
- 2014-03-01
- Expected to finish
- 2014-10-01
- Last updated by the study team
- 2021-03-17
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Miami, Florida, United States
Full record on ClinicalTrials.gov
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