Healthy volunteers test new drug interactions
NCT ID NCT06942936
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed Phase 1 study tested how a new drug called AZD5004 interacts with the antifungal itraconazole and with birth control pills in 51 healthy volunteers. The goal was to measure how these drugs affect each other's levels in the body, not to treat any disease. Results will help guide future dosing and safety for people who may take AZD5004 along with these common medications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AZD5004, itraconazole, and ethinyl estradiol/levonorgestrel (birth control pill)
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
51 people
The number who actually took part.
- Started
-
May 2025
- Finished
-
Jan 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 ≤ 30 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 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Research Site
Baltimore, Maryland, 21225, United States
-
Research Site
Berlin, 14050, Germany
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