Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD6234

Launched by ASTRAZENECA · Feb 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called AZD6234 to see how it affects people with different levels of kidney problems, including those with end-stage renal disease. The researchers want to understand how the body processes this medication in individuals with kidney impairment compared to healthy volunteers. The trial is currently recruiting participants aged 18 to 85, who either have chronic kidney disease and are stable or are healthy individuals with normal kidney function.

To be eligible, participants with kidney impairment must have stable renal function and be on a steady dose of relevant treatments for at least two weeks. They should also be free from certain health conditions that could interfere with the study. Healthy participants need to be in good health and meet specific criteria regarding their kidney function. Those who take part can expect to receive a single dose of the medication and will be monitored for safety and how well they tolerate it. It's important to note that both male and female participants of childbearing potential will need to use effective birth control during the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • - History or presence of: significant GI disease or previous upper GI surgery
• • Clinically significant cardiovascular disease, as judged by the investigator, d. Neuromuscular or neurogenic disease e. Severe vitamin D deficiency \< 12 ng/dL.
• • History or presence of any condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
• • History of psychosis, bipolar disorder
• • History of major depressive disorder within the past 2 years
• • History of suicide attempt or history of suicidal ideation within the past year.
• Healthy Matched Control Participants:
• • History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
• • Use of any prescription or non-prescription drugs, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
• Renally-impaired Participants:
• • Presence of unstable medical condition or any evidence of additional severe or uncontrolled systemic disease or laboratory finding which, in the opinion of the investigator, would compromise the participant's safety or successful participation in this study.
• • Renal transplant patients, participants waiting for organ transplant scheduled to occur during the study, and those with a history of acute kidney injury occurring within 3 months prior to screening. Nonfunctioning renal allografts are allowed.
• • Use of concurrent medication which affects calculation of eGFR by affecting serum creatinine within 7 days of Day -1.
• • Unable to refrain from phosphate binders, cholestyramine/colestipol, and ranitidine/nizatidine within 10 hours before and 10 hours after study intervention.