Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerabilit… (NCT07154901) | Clinical Trial Compass
RecruitingPhase 1
Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)
United States50 participantsStarted 2025-08-18
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Participant must be 18 to 80 years of age, inclusive, at the time of signing the informed consent. Type of Participant and Disease Characteristics For all participants, BSA-adjusted eGFR will be determined by the local laboratory, calculated based on serum creatinine using the CKD-EPI equation (see Section 4.1).
✓. Participant must be medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or 12-lead ECGs, as deemed by the investigator at screening and Day -1.
✓. Have an eGFR of ≥ 90 mL/min determined at screening.
✓. Group 2: have severe renal impairment (eGFR \< 30 mL/min), not requiring dialysis.
✓. Group 3 (optional): have moderate renal impairment (eGFR ≥ 30 to \< 60 mL/min)
✓. Group 4 (optional): have mild renal impairment (eGFR ≥ 60 to \< 90 mL/min) 6 Participants on angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, beta-blocker, diuretics, or on any other cardiorenal relevant treatment should be on a stable dose for at least 2 weeks prior to screening. Weight 7 Body weight of at least 50 kg and body mass index (BMI) within the range 18 to 40 kg/m2 (inclusive). Sex and Contraceptive/Barrier Requirements 8 Male and/or female, assigned at birth, inclusive of all gender identities. 9 Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion criteria
✕. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the investigator, at screening or Day -1, or history of hypersensitivity to drugs with a similar chemical structure or class to opemalirsen.
. History of any major surgical procedure within 30 days prior to study intervention.
✕. Judgement by the investigator that the participant should not participate in the study if they have any ongoing or recent (ie, during the screening period) minor medical complaints that may interfere with the interpretation of study data or if they are considered unlikely to comply with study procedures, restrictions, and requirements.
✕. Liver disease (non-alcoholic and alcoholic steatohepatitis; drug-induced, viral, or autoimmune hepatitis; primary biliary cirrhosis; primary sclerosing cholangitis; hemochromatosis; alpha-1 antitrypsin deficiency; Wilson's disease) including positive results for hepatitis B surface antigen, hepatitis B core antibody or hepatitis C virus antibody.
✕. History of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy, or variceal bleeding.
✕. QTcF \> 470 ms in participants without bundle branch block and \> 480 ms in participants with bundle branch block.
✕. Any of the following out of range laboratory values: