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)
AstraZeneca
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.
Description
This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study, that will be conducted in 2 parts, to examine the PK, safety, and tolerability of opemalirsen in male and female participants with severe renal impairment to matched participants with normal renal function; and, if necessary, participants with mild and moderate renal impairment to matched participants with normal renal function. Potential participants will be screened to assess their eligibility to enter the study within 28 days prior to first dose administration. Participants will be assigned to th…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- DrugOpemalirsen (AZD2373)
Single, subcutaneous injection of AZD2373
Locations (2)
- Research SiteMiami, Florida
- Research SiteOrlando, Florida