COMPLETED

A Study to Investigate the Impact of Multiple Doses of Itraconazole on AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants

Conditions

Healthy Participants Obesity Type 2 Diabetes

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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 impact of multiple doses of itraconazole on the pharmacokinetics (PK) of AZD5004 in healthy participants (Part A), and to assess the impact of multiple doses of AZD5004 on the PK of Combined Oral Contraceptives (COCs) in healthy female participants (Part B).

Official Title

An Open-label, Fixed-sequence and Two-part Study to Assess the Impact of Multiple Doses of Itraconazole on the Pharmacokinetics of AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on the Pharmacokinetics of Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants

Quick Facts

Study Start:2025-05-28

Study Completion:2026-01-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06942936

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 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Suitable veins for cannulation or repeated venipuncture. * All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit. * Females of childbearing potential must not be lactating, must agree to use approved method of contraceptive. * Sexually active fertile male participants with female partners of childbearing potential must adhere to the approved contraception methods. * Have a Body Mass Index (BMI) between ≥ 18.5 kg/m2 and ≤ 35 kg/m2 (at the time of screening) and weigh at least 50 kg. * Females of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following criteria: 1. Postmenopausal defined as amenorrhoea for at least 12 months following cessation of all exogenous hormonal treatments and Follicle-stimulating hormone (FSH) levels (\> 40 mIU/mL). 2. Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion. * Have a BMI between ≥ 23 kg/m2 and ≤ 30 kg/m2 and weigh at least 55 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. * History of acute pancreatitis (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy), chronic pancreatitis, gallstones, or elevation in serum lipase/pancreatic amylase at screening. * History or presence of any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention. * Abnormal laboratory values, hepatic disease, Human Immunodeficiency Virus (HIV) positive, abnormal vital signs, abnormalities in rhythm, uncontrolled thyroid disease. * Known smoker, history of alcohol, drug abuse or caffeine intake. * Use of prescribed or unsubscribed medication within 3 months prior to screening. * History of psychosis, bipolar disorder, major depressive disorder. * Vulnerable participants, e.g., kept in detention, protected adults under guardianship.

Inclusion Criteria

Exclusion Criteria

* Suitable veins for cannulation or repeated venipuncture.
* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
* Females of childbearing potential must not be lactating, must agree to use approved method of contraceptive.
* Sexually active fertile male participants with female partners of childbearing potential must adhere to the approved contraception methods.
* Have a Body Mass Index (BMI) between ≥ 18.5 kg/m2 and ≤ 35 kg/m2 (at the time of screening) and weigh at least 50 kg.
* Females of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following criteria:
1. Postmenopausal defined as amenorrhoea for at least 12 months following cessation of all exogenous hormonal treatments and Follicle-stimulating hormone (FSH) levels (\> 40 mIU/mL).
2. Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.
* Have a BMI between ≥ 23 kg/m2 and ≤ 30 kg/m2 and weigh at least 55 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.
* History of acute pancreatitis (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy), chronic pancreatitis, gallstones, or elevation in serum lipase/pancreatic amylase at screening.
* History or presence of any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
* Abnormal laboratory values, hepatic disease, Human Immunodeficiency Virus (HIV) positive, abnormal vital signs, abnormalities in rhythm, uncontrolled thyroid disease.
* Known smoker, history of alcohol, drug abuse or caffeine intake.
* Use of prescribed or unsubscribed medication within 3 months prior to screening.
* History of psychosis, bipolar disorder, major depressive disorder.
* Vulnerable participants, e.g., kept in detention, protected adults under guardianship.

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 Date2025-05-28

Study Completion Date2026-01-28

Study Record Updates

Study Start Date2025-05-28

Study Completion Date2026-01-28

Terms related to this study

Keywords Provided by Researchers

Obesity
Type 2 Diabetes

Additional Relevant MeSH Terms

Healthy Participants