This Phase I, open-label, parallel group study will investigate the single oral dose PK, safety, and tolerability of AZD4144 to male and female participants with mild, moderate, and severe hepatic impairment compared to matched controls with normal hepatic function.
Must have a diagnosis of chronic (≥ 6 months) and stable hepatic impairment (e.g., no clinically significant change in signs, symptoms, or laboratory parameters of hepatic disease status within 30 days prior to study screening, as determined by the investigator at screening and Day -1).
Must be classified by the investigator as CP Class A (Group 1), CP Class B (Group 2), or CP Class C (Group 3) at screening.
Participant must be stable on a concomitant medication and/or treatment regimen (defined as not starting a new treatment/medication[s] or a change in the dosage or frequency of the concomitant medication[s] within at least 2 weeks prior to screening).
Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 45 kg/m2, inclusive.
History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
Have Type 1 diabetes mellitus or T2DM (Group 4)
Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.
History of long QT syndrome or prolonged QTcF.
Parallel
AZD4144
DrugSingle oral dose of AZD4144 in participants from all groups
PK parameters AUCinf
area under the concentration-time curve from zero to infinity
PK parameter AUClast
area under the concentration-time curve from zero to the last measurable concentration
PK parameters AUC(0-144)
area under the curve from time zero to time 144hours post dose
PK parameter Cmax
maximum observed plasma concentration
PK parameters tmax
time to reach maximum observed plasma concentration
PK Parameters t1/2λz
half-life associated with terminal slope (λz)
PK Parameters CL/F
apparent total body clearance of drug from plasma after extravascular administration
PK Parameters Vz/F
apparent volume of distribution during the terminal phase after extravascular administration.
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