A Phase I, Multicentre, Single-Dose, Non-Randomised, Open-Label, Parallel-Group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD6234
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of single subcutaneous dose of AZD6234 with end stage renal disease, severe, and possibly moderate and mild renal impairment in comparison to a matched healthy control group.
• Participant must be 18 to 85 years of age, inclusive, at the time of signing the informed consent.
• Body weight ≥ 50 kg; BMI within the range of ≥ 18 to ≤ 40 kg/m2, as measured at screening.
⁃ Healthy Matched Control Participants:
• Participant must be medically healthy with no clinically significant medical history, or abnormalities in 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.
⁃ Renally-impaired Participants:
• Diagnosis of chronic kidney disease, stable renal function in the 3 months prior to dosing,
• Participants with renal impairment based on BSA-adjusted CKD-EPI equation at screening.
• All renally-impaired participants should be on a stable dose of cardio-renal relevant treatment for at least 2 weeks prior to screening.
• If participants with renal impairment have diabetes mellitus, it must be controlled
• Female(s) of childbearing potential: must use adequate contraception. Oral contraceptives are not permitted as there is a potential effect of the IMP on the absorption of oral drugs.
• Male Participants: Condom use is required for the duration of the study and until at least 28 days after the last dose of IMP. Additional contraception must be used for the sexual partners of male study participants throughout the clinical trial and for 28 days following the last dose of IMP.