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

NCT06845813 | Completed Phase 1 FDA Drug

• 1 other identifier: D8750C00007
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Renal Impairment

Keywords

Renal Impairment; Healthy Participants; AZD6234; Pharmacokinetics; Safety

Outcome Measures

Primary Outcomes (3)

• AUClast

  Area under plasma concentration-time curve from time zero to the last measurable concentration

  Day 1 to Day 36

• AUCinf

  Area under plasma concentration-time curve from zero to infinity

  Day 1 to Day 36

• Cmax

  Maximum observed plasma concentration

  Day 1 to Day 36

Secondary Outcomes (11)

• Tmax

  Day 1 to Day 36

• PK parameter (t1/2λz)

  Day 1 to Day 36

• PK parameter (CL/F)

  Day 1 to Day 36

• PK parameter (Vz/F)

  Day 1 to Day 36

• Number of participants with adverse events (AEs)

  Day 1 to Day 54

Study Arms (5)

Group 1

EXPERIMENTAL

Subjects with end stage renal disease will receive a single subcutaneous dose of AZD6234 under fasted conditions

Drug: AZD6234

Group 2

EXPERIMENTAL

Subjects with severe renal impairment will receive a single subcutaneous dose of AZD6234 under fasted conditions

Drug: AZD6234

Group 3

EXPERIMENTAL

Healthy participants will receive a single subcutaneous dose of AZD6234 under fasted conditions

Drug: AZD6234

Group 4 (optional)

EXPERIMENTAL

Subjects with moderate renal impairment will receive a single subcutaneous dose of AZD6234 under fasted conditions

Drug: AZD6234

Group 5 (optional)

EXPERIMENTAL

Subjects with mild renal impairment will receive a single subcutaneous dose of AZD6234 under fasted conditions

Drug: AZD6234

Interventions

AZD6234 DRUG

Dose 1

Also known as: Dose 1

Group 1; Group 2; Group 3; Group 4 (optional); Group 5 (optional)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (3)

Research Site

Lake Forest, California, 92630, United States

Location

Research Site

Orlando, Florida, 32808, United States

Location

Research Site

Orlando, Florida, 32809, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Fadi Saba, M.D.

  Servico Integrado de Tecnicas Endovasculares

  PRINCIPAL INVESTIGATOR

• Thomas C Marbury, M.D.

  Servico Integrado de Tecnicas Endovasculares

  PRINCIPAL INVESTIGATOR

• Joel M Neutel, M.D.

  Servico Integrado de Tecnicas Endovasculares

  PRINCIPAL INVESTIGATOR

• Kwabena Ayesu, M.D.

  Servico Integrado de Tecnicas Endovasculares

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Up to five cohorts (four renal impairment cohorts and controls with normal renal function) will be enrolled into the study. All subjects will receive the study intervention: * Cohort 1 will enroll participants with end stage renal disease * Cohort 2 will enroll participants with severe renal impairment * Cohort 3 will enroll healthy participants matched on a group level by sex, age, and BMI * Cohort 4 (optional) will enroll participants with moderate renal impairment * Cohort 5 (optional) will enroll participants with mild renal impairment

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 25, 2025
• Study Start: February 24, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Locations

US (3)