COMPLETED

A Study in Healthy Participants to Investigate Relative Bioavailability of AZD5004 in Three Solid Oral Formulations

Conditions

Healthy Participants Relative bioavailability GLP-1 receptor agonist Type 2 Diabetes Mellitus Obesity Oral tablet formulations

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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

The purpose of this study is to assess the relative bioavailability of a single dose AZD5004 in healthy participants, among 3 different oral tablet formulations.

Official Title

An Open-Label, Randomized, Four-Treatment, Four-Period, Single-Dose Crossover Study in Healthy Participants to Assess the Relative Bioavailability of AZD5004 in Three Solid Oral Formulations (F1, F3, F4)

Quick Facts

Study Start:2025-05-22

Study Completion:2025-07-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06996886

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 with suitable veins for cannulation or repeated venipuncture. * Female participants: 1. Female(s) of childbearing potential: If heterosexually active must agree to use an approved method of highly effective contraception. 2. Female(s) not of childbearing potential * Male participants: 1. Condom use is required for the duration of the clinical study. 2. Additional contraception must be used for the sexual partners of male study participants throughout the clinical study. * Have a Body Mass Index (BMI) ≥ 23 kg/m2 and not exceeding 35 kg/m2 inclusive (at the time of Screening) and weigh at least 60 kg.	* History of any clinically important 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 * History of acute pancreatitis (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy), chronic pancreatitis, gallstones, or elevation in serum lipase/pancreatic amylase. * Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract (including bariatric surgery). * Any clinically important illness, medical/surgical procedure, or trauma. * Any laboratory values with the deviations specified in protocol and clinically important abnormalities in clinical chemistry, hematology, or urinalysis results. * Any positive result at Screening for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb) or Human immunodeficiency Virus (HIV). * Abnormal vital signs, after 10 minutes supine rest, at Screening and/or admission to the Clinical Unit. * Serum triglyceride concentrations above 1000 mg/dL (11 mmol/L). * Basal calcitonin level \> 50 ng/L or pg/mL at Screening or history/family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN), type 2. * Known or suspected history of alcohol or drug abuse or excessive intake of alcohol * Positive screen for drugs of abuse, or alcohol or cotinine (nicotine). * 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 AZD5004. * Excessive intake of caffeine-containing drinks or food * History of psychosis or bipolar disorder and major depressive disorder. * History of suicide attempt or history of suicidal ideation within the past year.

Inclusion Criteria

Exclusion Criteria

* Healthy male and female participants with suitable veins for cannulation or repeated venipuncture.
* Female participants:
1. Female(s) of childbearing potential: If heterosexually active must agree to use an approved method of highly effective contraception.
2. Female(s) not of childbearing potential
* Male participants:
1. Condom use is required for the duration of the clinical study.
2. Additional contraception must be used for the sexual partners of male study participants throughout the clinical study.
* Have a Body Mass Index (BMI) ≥ 23 kg/m2 and not exceeding 35 kg/m2 inclusive (at the time of Screening) and weigh at least 60 kg.

* History of any clinically important 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
* History of acute pancreatitis (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy), chronic pancreatitis, gallstones, or elevation in serum lipase/pancreatic amylase.
* Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract (including bariatric surgery).
* Any clinically important illness, medical/surgical procedure, or trauma.
* Any laboratory values with the deviations specified in protocol and clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
* Any positive result at Screening for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb) or Human immunodeficiency Virus (HIV).
* Abnormal vital signs, after 10 minutes supine rest, at Screening and/or admission to the Clinical Unit.
* Serum triglyceride concentrations above 1000 mg/dL (11 mmol/L).
* Basal calcitonin level \> 50 ng/L or pg/mL at Screening or history/family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN), type 2.
* Known or suspected history of alcohol or drug abuse or excessive intake of alcohol
* Positive screen for drugs of abuse, or alcohol or cotinine (nicotine).
* 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 AZD5004.
* Excessive intake of caffeine-containing drinks or food
* History of psychosis or bipolar disorder and major depressive disorder.
* History of suicide attempt or history of suicidal ideation within the past year.

Contacts and Locations

Study Locations (Sites)

Research Site

Baltimore, 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 Date2025-05-22

Study Completion Date2025-07-25

Study Record Updates

Study Start Date2025-05-22

Study Completion Date2025-07-25

Terms related to this study

Keywords Provided by Researchers

Relative bioavailability
GLP-1 receptor agonist
Type 2 Diabetes Mellitus
Obesity
Oral tablet formulations

Additional Relevant MeSH Terms

Healthy Participants