Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: * Participants are eligible to be included in the study only if all of the following criteria apply: Age 1. 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). Healthy matched control participants only (Group 1): 2. 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. 3. Have an eGFR of ≥ 90 mL/min determined at screening. Participants with renal impairment only (Group 2 and optional Groups 3 and 4): 4 Diagnosis of chronic kidney disease with stable renal function in the 3 months prior to dosing, as determined by the investigator, based on me