Hepatic Impairment
Conditions
Keywords
Phase 1, hepatic impairment
Brief summary
To evaluate the pharmacokinetics, safety, and tolerability of IPI-145 when administered to subjects with chronic hepatic impairment and in matched healthy subjects.
Detailed 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.
Interventions
DRUGIPI-145
25 mg single oral capsule
Sponsors
SecuraBio
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameters of IPI-145 and its primary metabolite, IPI-656 | Open 72 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events following administration of IPI-145 | 10 days | Safety Findings |
Countries
United States
Outcome results
None listed