RECRUITING

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4248 in Healthy Participants and Participants With Chronic Kidney Disease and Type 2 Diabetes and to Assess Home Measurements of Creatinine in a Non Interventional Cohort

Conditions

Chronic Kidney Disease Type 2 Diabetes Diabetic Kidney Disease Multiple Ascending Dose Single Ascending Dose Creatinine Food Effect 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 safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses (SAD) and multiple ascending doses (MAD) of AZD4248 administered as an oral solution and intravenous (IV) infusion. Additionally, the study investigates the non-interventional feasibility of home measurement of serum creatinine in participants with diabetic kidney disease (DKD).

Official Title

A Phase I Randomized, Single-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4248 Following Single and Multiple Ascending Dose Administration in Healthy Participants and Participants With Chronic Kidney Disease and Type 2 Diabetes and to Assess Home Measurements of Creatinine in a Prospective, Non-interventional Cohort Study

Quick Facts

Study Start:2025-06-09

Study Completion:2026-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07024823

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 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Have a body mass index (BMI) between 18 and 30 kilograms per millimeter (kg/m2), inclusive. * For Chinese participants (Part A2): participants are to be Chinese, defined as having both parents and 4 grandparents who are Chinese. This includes second and third generation participants of Chinese descent whose parents or grandparents are living in a country other than China. * For Japanese participants (Part B2): participants are to be Japanese, defined as having both parents and 4 grandparents who are Japanese. This includes second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan. * Have a BMI between 20 and 35 kg/m2, inclusive. * Have a diagnosis of diabetic kidney disease (DKD). * Hemoglobin A1C (HbA1c) of ≤ 10.5%. * Participants are required to be on a stable dose of angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 6 weeks prior to Visit 1 and throughout the Screening Period. In addition, participants should be on stable doses of all other medication for ≥ 6 weeks before Screening. * Have a BMI between 20 and 35 kg/m2, inclusive. * Have a diagnosis of DKD as defined by a) diagnosis of type 2 diabetes (T2D) b) eGFR values and c) urine albumin to creatinine ratio (UACR) values. * HbA1c of ≤ 10.5%. * Participants are required to be on a stable dose of ACEi or ARB for at least 6 weeks prior to Visit 1 and throughout the Screening Period. In addition, participants should be on stable doses of all other medication for ≥ 6 weeks before Screening. * Participants must be able and motivated to use the home creatinine device and smartphone independently by successfully performing the test without assistance from site staff. * Participants must be able to read and understand English sufficient to participate in site visits and home testing.	* History of any clinically important disease or disorder which may put the participant at risk because of participation in the study or influence the results. * Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or human immunodeficiency virus (HIV). * History or presence of gastrointestinal, hepatic, or renal disease. * Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention. * History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4248. * Participants who have previously received AZD4248. * History or presence of gastrointestinal, hepatic, or renal disease. * Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention. * History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4248. * Use of drugs that are strong or moderate CYP3A4 inhibitors/inducers or P-gp inhibitors from within 3 weeks before Screening until the end of the last sample collection. * Participants who have previously received AZD4248. * Participants on serum creatinine-altering drugs should be on long-term treatment at a stable dose prior to study entry. * Expected change of dosing regimen during the study. * History of clinically significant heart or vascular disease. * New York Heart Association Class 2, 3, or 4 or history of hospitalization for heart failure within 6 months of screening. * Ventricular arrhythmias requiring treatment. * Amputation due to peripheral artery disease. * Severe chronic obstructive pulmonary disease as judged by the Investigator or hospitalization for exacerbation in the last 6 months. * Participants on serum creatinine-altering drugs should be on long-term treatment at a stable dose prior to study entry. * Expected change of dosing regimen during the study.

Inclusion Criteria

Exclusion Criteria

* Have a body mass index (BMI) between 18 and 30 kilograms per millimeter (kg/m2), inclusive.
* For Chinese participants (Part A2): participants are to be Chinese, defined as having both parents and 4 grandparents who are Chinese. This includes second and third generation participants of Chinese descent whose parents or grandparents are living in a country other than China.
* For Japanese participants (Part B2): participants are to be Japanese, defined as having both parents and 4 grandparents who are Japanese. This includes second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.
* Have a BMI between 20 and 35 kg/m2, inclusive.
* Have a diagnosis of diabetic kidney disease (DKD).
* Hemoglobin A1C (HbA1c) of ≤ 10.5%.
* Participants are required to be on a stable dose of angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 6 weeks prior to Visit 1 and throughout the Screening Period. In addition, participants should be on stable doses of all other medication for ≥ 6 weeks before Screening.
* Have a BMI between 20 and 35 kg/m2, inclusive.
* Have a diagnosis of DKD as defined by a) diagnosis of type 2 diabetes (T2D) b) eGFR values and c) urine albumin to creatinine ratio (UACR) values.
* HbA1c of ≤ 10.5%.
* Participants are required to be on a stable dose of ACEi or ARB for at least 6 weeks prior to Visit 1 and throughout the Screening Period. In addition, participants should be on stable doses of all other medication for ≥ 6 weeks before Screening.
* Participants must be able and motivated to use the home creatinine device and smartphone independently by successfully performing the test without assistance from site staff.
* Participants must be able to read and understand English sufficient to participate in site visits and home testing.

* History of any clinically important disease or disorder which may put the participant at risk because of participation in the study or influence the results.
* Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or human immunodeficiency virus (HIV).
* History or presence of gastrointestinal, hepatic, or renal disease.
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4248.
* Participants who have previously received AZD4248.
* History or presence of gastrointestinal, hepatic, or renal disease.
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4248.
* Use of drugs that are strong or moderate CYP3A4 inhibitors/inducers or P-gp inhibitors from within 3 weeks before Screening until the end of the last sample collection.
* Participants who have previously received AZD4248.
* Participants on serum creatinine-altering drugs should be on long-term treatment at a stable dose prior to study entry.
* Expected change of dosing regimen during the study.
* History of clinically significant heart or vascular disease.
* New York Heart Association Class 2, 3, or 4 or history of hospitalization for heart failure within 6 months of screening.
* Ventricular arrhythmias requiring treatment.
* Amputation due to peripheral artery disease.
* Severe chronic obstructive pulmonary disease as judged by the Investigator or hospitalization for exacerbation in the last 6 months.
* Participants on serum creatinine-altering drugs should be on long-term treatment at a stable dose prior to study entry.
* Expected change of dosing regimen during the study.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479

information.center@astrazeneca.com

Study Locations (Sites)

Research Site

Glendale, California, 91206

United States

Research Site

San Antonio, Texas, 78215

United States

Collaborators and Investigators

Sponsor: AstraZeneca

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 Date2025-06-09

Study Completion Date2026-04-30

Study Record Updates

Study Start Date2025-06-09

Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

Type 2 Diabetes
Diabetic Kidney Disease
Multiple Ascending Dose
Single Ascending Dose
Creatinine
Food Effect
Pharmacokinetics
Safety

Additional Relevant MeSH Terms

Chronic Kidney Disease