This study is designed to assess the safety, tolerability and pharmacokinetics of ABI-6250 in participants with mild hepatic impairment compared with participants with normal hepatic function.
Participant is willing and able to provide written informed consent, is available for the entire study period, is able to understand and comply with study requirements, procedures and restrictions, able to remain at the clinical research unit (CRU) for the required study duration and return to the CRU for outpatient assessments.
Participant has a body mass index (BMI) of 18.0 to 45.0 kg/m2, is a non/ex/light-smoker, and is willing and able to swallow whole tablets without breaking, butting or chewing.
Renal function, as measured by eGFR calculated using the 2009 CKD-EPI equation >60 mL/min at Screening.
Female participants must be nonpregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -2.
Child-Pugh score >6 at Screening.
Female participant who is currently pregnant or lactating, or is planning to become pregnant during the study through EOS.
Positive test results for HAV IgM, HBcAb IgM, HBsAg, or HIV 1/2 Ab at Screening.
Positive screen for drugs or alcohol (listed in Table 5) at Screening or on Day -2, with the exception of prescription medication (including THC) as determined by the Investigator to be therapeutic.
Single group
ABI-6250
DrugParticipants will receive ABI-6250 0.5 mg QD over 10 days.
Maximum Observed Plasma Concentration (Cmax) of ABI-6250.
Apparent Terminal Elimination Half Life (t 1/2) of ABI-6250.
Time to Cmax (Tmax) of ABI-6250.
Area Under the Plasma Concentration-Time Curve (AUC) from time zero to 24 hours postdose (AUC0-24) of ABI-6250 on Days 1 and 10.
Bile acid levels in plasma.
Coproporphyrin 1 (CP-1) levels in plasma.
Unbound Cmax (Cmax,u) of ABI-6250.
Unbound AUC0-24 (AUC0-24,u) of ABI-6250.
Amount of bile acids excreted in urine.
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