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Healthy volunteers test new drug interactions

NCT ID NCT06942936

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.