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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
25 mg single oral capsule
Unnamed facility
Miami, Florida, United States
Pharmacokinetic parameters of IPI-145 and its primary metabolite, IPI-656
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
Time frame: Open 72 hours
Incidence of adverse events following administration of IPI-145
Safety Findings
Time frame: 10 days
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