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A Single Dose, Non-randomised, Open-label, Parallel Group Study to Assess the Pharmacokinetics, PCSK9 Reduction, Safety, and Tolerability of AZD8233 in Participants With Severe Renal Impairment, End Stage Renal Disease and Healthy Participants as Controls
The study is intended to assess the pharmacokinetics (PK), proprotein convertase subtilisin/kexin type 9 (PCSK9) reduction, safety and tolerability of AZD8233 in male and female participants with severe renal impairment and participants with ESRD compared to matched healthy control participants.
This is an open-label, single dose, non-randomised, parallel group study. Participant will be enrolled in 3 cohorts. * Cohort 1 will include 8 participants with severe renal impairment (estimated glomerular filtration rate \[eGFR\] of ≥15 to \< 30 mL/min/1.73 m\^2). * Cohort 2 will include 8 healthy participants with normal renal function (eGFR of ≥ 90 mL/min/1.73 m\^2) that will serve as matched controls for Cohort 1 and Cohort 3. Matching will account for age, Body mass index (BMI), and gender. * Cohort 3 will include 8 participants with ESRD on dialysis (eGFR of \< 15 mL/min/1.73 m\^2). * Participants in Cohort 3 will receive a single dose of AZD8233 the day after haemodialysis. Participant will receive the study drug on Day 1, discharged on Day 2 followed by out-patient follow-up visits on Day 3, 7, 14, 28, 42, 56, and 90.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
Yes
Research Site
Gdansk, Poland
Start Date
August 10, 2022
Primary Completion Date
November 23, 2022
Completion Date
November 23, 2022
Last Updated
December 22, 2022
3
ACTUAL participants
AZD8233
DRUG
Lead Sponsor
AstraZeneca
Collaborators
NCT07146854
NCT04163614
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT04580420