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

Launched by ASTRAZENECA · Apr 17, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring how two medications interact with each other in healthy people. In the first part of the study, researchers will look at how multiple doses of a drug called itraconazole affect another drug called AZD5004. In the second part, they will see how AZD5004 influences the effectiveness of common birth control pills that contain ethinyl estradiol and levonorgestrel. The goal is to understand these interactions better, which can help ensure safety and effectiveness for future patients.

To be eligible for the trial, participants need to be healthy and fall within certain age and weight ranges. For example, men and women must have a BMI (body mass index) within specific limits and meet certain health criteria, like having suitable veins for blood tests and not having any major health issues. Women must also confirm they are not pregnant and agree to use birth control if they can become pregnant. Participants will be monitored closely during the study, and they can expect regular check-ups and tests to ensure their safety. It's important to note that this trial is not yet recruiting participants, so those interested will need to wait for it to begin.

Gender

ALL

Eligibility criteria

• Main Inclusion Criteria:
• • Part A -
• • 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.
• • Part B -
• * 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 ≤ 35 kg/m2 and weigh at least 55 kg.
• Main Exclusion Criteria:
• • Part A and Part B-
• • 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.
• • 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.