AZD4144: Single oral dose of AZD4144 in participants from all groups
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria:
Healthy Matched Control Participants Only (Group 4):
• Must be medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or 12-lead ECGs, as deemed by the investigator at screening and Day -1.
Hepatically-Impaired Participants Only (Groups 1, 2, and 3):
* 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).
All Groups:
* Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 45 kg/m2, inclusive.
* All Females of Childbearing Potential (FOCBP) must have a negative pregnancy test at screening and Day -1.
Exclusion Criteria:
* 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.
* Presence of unstable medical or psychological conditions, or any evidence of additional severe or uncontrolled systemic disease (e.g., currently unstable or uncompensated renal, cardiovascular, or respiratory disease).
* Evidence of renal impairment at screening
* Current liver transplant or anticipated to receive liver transplant within 2 months of screening or Day -1 (Group 1, 2 and 3).
* Use of any of the prescription and non-prescription prohibited medications.
* Concomitant immunosuppressive, steroid treatment.
* Live or attenuated vaccines within 3 months prior to study intervention or live vaccinations planned during the trial.
* History of severe allergy/hypersensitivity of AZD4144 or any of the excipients of the product.
* Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days prior to study intervention in this study or, if known, 5 half-lives from last dose in the previous study to study intervention in this study, whichever is longest.
Primary outcome measure(s)
PK parameters AUCinf — Day 0 through Day 7 or 9 area under the concentration-time curve from zero to infinity
PK parameter AUClast — Day 0 through Day 7 or 9 area under the concentration-time curve from zero to the last measurable concentration
PK parameters AUC(0-144) — Day 0 through Day 7 area under the curve from time zero to time 144hours post dose
PK parameter Cmax — Day 0 through Day 7 or 9 maximum observed plasma concentration
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.