COMPLETED

A Study to Investigate the Effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the Effect of Erythromycin on AZD5004 in Healthy Participants

Conditions

Healthy Participants Obesity Type 2 Diabetes Mellitus (T2DM)Pharmacokinetics

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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 assess the effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the effect of Erythromycin on AZD5004 in healthy adult male and female participants.

Official Title

An Open-label, Fixed-sequence, Three-part Study to Assess the Effect of AZD5004 on the Pharmacokinetics of Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and to Assess the Effect of Erythromycin on AZD5004 in Healthy Participants

Quick Facts

Study Start:2025-05-06

Study Completion:2025-10-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06948747

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 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Healthy male and female participants aged 18 to 55 years * All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit. * Female(s) of childbearing potential if heterosexually active, must agree to use an approved method of highly effective contraception. * Male participants must use condoms for the duration of clinical trial. * Additional contraception must be used for the sexual partners of male trial participants throughout the clinical trial. * Have a body mass index (BMI) between ≥ 20.0 and ≤ 35 kg/m2 (at the time of screening) inclusive and weigh at least 50 kg.	* History of any clinically important disease or disorder (liver transplant, liver disease, positive for serum HBsAg (Hepatitis B surface antigen) OR anti-HBcAb (Hepatitis B core antibody), positive for anti-HCV (Hepatitis C virus), history of cirrhosis and/or hepatic decompensation, cardiovascular disease, neuromuscular or neurogenic disease. * History of Type 1 or Type 2 diabetes mellitus (DM). * History of Hemoglobin A1c ≥ 6.5% (≥ 48 mmol/mol) at screening. * History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * Any clinically important illness, medical/surgical procedure, or trauma. * Any laboratory values with deviations or clinically important abnormalities in clinical chemistry, hematology, or urinalysis at the Screening Visit or on admission to the Clinical Unit. * Significant hepatic disease as judged by the investigator. * Any positive result on screening for serum HBsAg, HBcAb or HIV (Human immunodeficiency virus). * Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12 lead ECG, at screening * Abnormal vital signs. * Uncontrolled thyroid disease or history/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2). * Current smokers or those who have smoked or used nicotine products. * Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the investigator. Excessive intake of alcohol defined as the regular consumption of more than 24 g of alcohol per day for men or 12 g of alcohol per day for females. * Positive screen for drugs of abuse, or alcohol or cotinine at screening or on each admission to the Clinical Unit. * History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity. * Excessive intake of caffeine-containing drinks or food * History of psychosis or bipolar disorder or major depressive disorder or suicide attempt or suicidal ideation.

Inclusion Criteria

Exclusion Criteria

* Healthy male and female participants aged 18 to 55 years
* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
* Female(s) of childbearing potential if heterosexually active, must agree to use an approved method of highly effective contraception.
* Male participants must use condoms for the duration of clinical trial.
* Additional contraception must be used for the sexual partners of male trial participants throughout the clinical trial.
* Have a body mass index (BMI) between ≥ 20.0 and ≤ 35 kg/m2 (at the time of screening) inclusive and weigh at least 50 kg.

* History of any clinically important disease or disorder (liver transplant, liver disease, positive for serum HBsAg (Hepatitis B surface antigen) OR anti-HBcAb (Hepatitis B core antibody), positive for anti-HCV (Hepatitis C virus), history of cirrhosis and/or hepatic decompensation, cardiovascular disease, neuromuscular or neurogenic disease.
* History of Type 1 or Type 2 diabetes mellitus (DM).
* History of Hemoglobin A1c ≥ 6.5% (≥ 48 mmol/mol) at screening.
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically important illness, medical/surgical procedure, or trauma.
* Any laboratory values with deviations or clinically important abnormalities in clinical chemistry, hematology, or urinalysis at the Screening Visit or on admission to the Clinical Unit.
* Significant hepatic disease as judged by the investigator.
* Any positive result on screening for serum HBsAg, HBcAb or HIV (Human immunodeficiency virus).
* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12 lead ECG, at screening
* Abnormal vital signs.
* Uncontrolled thyroid disease or history/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2).
* Current smokers or those who have smoked or used nicotine products.
* Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the investigator. Excessive intake of alcohol defined as the regular consumption of more than 24 g of alcohol per day for men or 12 g of alcohol per day for females.
* Positive screen for drugs of abuse, or alcohol or cotinine at screening or on each admission to the Clinical Unit.
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
* Excessive intake of caffeine-containing drinks or food
* History of psychosis or bipolar disorder or major depressive disorder or suicide attempt or suicidal ideation.

Contacts and Locations

Study Locations (Sites)

Research Site

Brooklyn, Maryland, 21225

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 Date2025-05-06

Study Completion Date2025-10-03

Study Record Updates

Study Start Date2025-05-06

Study Completion Date2025-10-03

Terms related to this study

Keywords Provided by Researchers

Obesity
Type 2 Diabetes Mellitus (T2DM)
Pharmacokinetics

Additional Relevant MeSH Terms

Healthy Participants