RecruitingPhase 1NCT07154901

Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)

A Single-Dose, Non-Randomised, Open-Label, Parallel-Group Study to Investigate the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)


Sponsor

AstraZeneca

Enrollment

50 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is being conducted to investigate the PK, safety, and tolerability of opemalirsen in participants with renal impairment, compared to participants with normal renal function.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how kidney function affects the way the body processes a drug called opemalirsen (AZD2373). Participants with varying degrees of kidney impairment will be compared to healthy volunteers to understand if kidney disease changes how the drug behaves. **You may be eligible if...** - You are between 18 and 80 years old - You are either a healthy volunteer with normal kidney function, OR you have stable chronic kidney disease not requiring dialysis - Your body weight is at least 50 kg and your BMI is between 18 and 40 - You are willing to use appropriate contraception **You may NOT be eligible if...** - You have liver disease, cirrhosis, or a history of hepatitis B or C - You have HIV - You have a history of drug or alcohol abuse in the past year - Your kidney function is rapidly declining - You have had a kidney transplant - You have had major surgery within the past 30 days - You have abnormal heart rhythm (prolonged QT interval) - You have been in another drug study within the past 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOpemalirsen (AZD2373)

Single, subcutaneous injection of AZD2373


Locations(2)

Research Site

Miami, Florida, United States

Research Site

Orlando, Florida, United States

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NCT07154901


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