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Clinical Trial Summary

The study is intended to assess the pharmacokinetics (PK), proprotein convertase subtilisin/kexin type 9 (PCSK9) reduction, safety and tolerabilityof AZD8233 in male and female participants with severe renal impairment and participants with ESRD compared to matched healthy control participants.

Clinical Trial Description

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). - Cohort 3 will include 12 participants with ESRD on dialysis (eGFR of < 15 mL/min/1.73 m^2). Cohort 3 will be sub-divided into 2 cohorts, Cohort 3a and Cohort 3b (8 and 4 participants respectively). - Participants in Cohort 3a will receive a single dose of AZD8233 the day after haemodialysis. - Participants in Cohort 3b will receive a single SC dose of AZD8233 1 hour before the start of the 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05065463
Study type Interventional
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date October 27, 2021
Completion date April 18, 2023

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