NCT05065463

To Assess the Pharmacokinetics, Safety, and Tolerability of AZD8233 in Participants With Chronic Kidney Disease (CKD), End Stage Renal Disease (ESRD) and Healthy Participants.

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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) 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.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	AZD8233	Participants will receive a single subcutaneous (SC) dose of AZD8233 into the region of the abdomen.

Timeline

• Start date: 2022-08-10
• Primary completion: 2022-11-23
• Completion: 2022-11-23
• First posted: 2021-10-04
• Last updated: 2022-12-22

Locations

1 site across 1 country: Poland

Regulatory

• FDA-regulated drug study