COMPLETED

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

Conditions

Renal Impairment Healthy Participants AZD6234 Pharmacokinetics Safety

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02-24

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06845813

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.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Principal Investigator

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 Locations (Sites)

Research Site

Lake Forest, California, 92630

United States

Research Site

Orlando, Florida, 32808

United States

Research Site

Orlando, Florida, 32809

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-24

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2025-02-24

Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

Renal Impairment
Healthy Participants
AZD6234
Pharmacokinetics
Safety

Additional Relevant MeSH Terms

Renal Impairment