Actively Recruiting
Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)
Led by AstraZeneca · Updated on 2026-02-24
50
Participants Needed
2
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years, inclusive
- Healthy participants (Group 1) must have no significant medical history or abnormalities and an eGFR 6 mL/min
- Participants with renal impairment (Groups 2-4) must have chronic kidney disease with stable renal function and not require dialysis
- Group 2: severe renal impairment with eGFR < 30 mL/min
- Group 3 (optional): moderate renal impairment with eGFR 30 to < 60 mL/min
- Group 4 (optional): mild renal impairment with eGFR 60 to < 90 mL/min
- Stable dose of cardiorenal treatments for at least 2 weeks prior to screening if applicable
- Body weight at least 50 kg and BMI between 18 and 40 kg/m2
- Male and female participants of all gender identities
- Female participants must not be pregnant, must test negative for pregnancy, and use highly effective contraception if of childbearing potential
- Male participants must agree to contraception guidance from dosing until 3 months after discharge
You will not qualify if you...
- History of severe allergy or hypersensitivity to opemalirsen or similar drugs
- Major surgery within 30 days before dosing
- Any medical or psychological condition interfering with study participation or safety
- Liver disease or positive hepatitis B/C tests
- History of cirrhosis or hepatic decompensation
- Abnormal QTc intervals on ECG
- Laboratory abnormalities including elevated liver enzymes, abnormal coagulation, or HbA1c 10%
- HIV positive test
- Drug or alcohol abuse within 1 year
- For healthy controls: any clinically significant disease, abnormal vital signs, or medication use within specified times
- For renal impairment groups: rapidly deteriorating kidney function, unstable medical conditions, recent kidney transplant or acute kidney injury
- Use of medications affecting creatinine clearance within 7 days prior to dosing
- Recent participation in other clinical trials or exposure to new chemical entities
- Positive drug or alcohol screening (except for prescribed medications in renal impairment)
- Recent blood product or donation within specified timeframes
- Employment or close relation to AstraZeneca or clinical unit staff
- Vulnerable participants under legal protection or detention
- Investigator judgment of non-compliance or safety concerns
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Research Site
Miami, Florida, United States, 33172
Actively Recruiting
2
Research Site
Orlando, Florida, United States, 32808
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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