RECRUITING

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

Description

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Renal Impairment
Intervention / Treatment

-

Contacts and Locations

Lake Forest

Research Site, Lake Forest, California, United States, 92630

Orlando

Research Site, Orlando, Florida, United States, 32808

Orlando

Research Site, Orlando, Florida, United States, 32809

Tampa

Research Site, Tampa, Florida, United States, 33618

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.
  • * 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.
  • * 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.
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

AstraZeneca,

Fadi Saba, M.D., PRINCIPAL_INVESTIGATOR, Servico Integrado de Tecnicas Endovasculares

Thomas C Marbury, M.D., PRINCIPAL_INVESTIGATOR, Servico Integrado de Tecnicas Endovasculares

Joel M Neutel, M.D., PRINCIPAL_INVESTIGATOR, Servico Integrado de Tecnicas Endovasculares

Kwabena Ayesu, M.D., PRINCIPAL_INVESTIGATOR, Servico Integrado de Tecnicas Endovasculares

Study Record Dates

2025-10-02