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

Last updated: March 5, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

1

Condition

Focal Segmental Glomerulosclerosis

Kidney Failure

Kidney Failure (Pediatric)

Treatment

AZD6234

Clinical Study ID

NCT06845813
D8750C00007
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be 18 to 85 years of age, inclusive, at the time of signing theinformed consent.

  • Body weight ≥ 50 kg; BMI within the range of ≥ 18 to ≤ 40 kg/m2, as measured atscreening.

Healthy Matched Control Participants:

  • Participant must be medically healthy with no clinically significant medicalhistory, 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 todosing,

  • Participants with renal impairment based on BSA-adjusted CKD-EPI equation atscreening.

  • All renally-impaired participants should be on a stable dose of cardio-renalrelevant 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. Oralcontraceptives are not permitted as there is a potential effect of the IMP on theabsorption of oral drugs.

  • Male Participants: Condom use is required for the duration of the study and until atleast 28 days after the last dose of IMP. Additional contraception must be used forthe sexual partners of male study participants throughout the clinical trial and for 28 days following the last dose of IMP.

Exclusion

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 ofthe investigator, may either put the participant at risk because of participation inthe study, or influence the results or the participant's ability to participate inthe study.

  • Use of any prescription or non-prescription drugs, unless, in the opinion of theinvestigator and sponsor, the medication will not interfere with the study.

Renally-impaired Participants:

  • Presence of unstable medical condition or any evidence of additional severe oruncontrolled systemic disease or laboratory finding which, in the opinion of theinvestigator, would compromise the participant's safety or successful participationin this study.

  • Renal transplant patients, participants waiting for organ transplant scheduled tooccur during the study, and those with a history of acute kidney injury occurringwithin 3 months prior to screening. Nonfunctioning renal allografts are allowed.

  • Use of concurrent medication which affects calculation of eGFR by affecting serumcreatinine within 7 days of Day -1.

  • Unable to refrain from phosphate binders, cholestyramine/colestipol, andranitidine/nizatidine within 10 hours before and 10 hours after study intervention.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: AZD6234
Phase: 1
Study Start date:
February 24, 2025
Estimated Completion Date:
October 02, 2025

Study Description

This Phase I multicentre, single-dose, non-randomised, open-label, parallel-group study aims to examine the pharmacokinetics, safety, and tolerability of AZD6234 in both male and female participants. Participants include those with end-stage renal disease (ESRD) on intermittent haemodialysis (HD), severe renal impairment not on dialysis, and optional groups for moderate and mild renal impairment. These are compared to participants with normal renal function. All participants are grouped based on body surface area-adjusted estimated glomerular filtration rate (eGFR), and those with normal renal function are matched at a group level by sex, age, and body mass index (BMI) to the participants with impaired renal function.

Connect with a study center

  • Research Site

    Lake Forest, California 92630
    United States

    Site Not Available

  • Research Site

    Orlando, Florida 32808
    United States

    Active - Recruiting

  • Research Site

    Tampa, Florida 33618
    United States

    Site Not Available

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