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New drug interaction study launches in healthy volunteers

NCT ID NCT07444424

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Updated 3 times

Summary

This early-stage study in 32 healthy adults looks at how a new drug called AZD5004 changes the way the body processes two diabetes medications, mitiglinide and pioglitazone. The goal is to understand potential drug interactions, not to treat any disease. Participants take the drugs in a fixed order, and researchers measure drug levels and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZD5004

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

32 people

The number who actually took part.

Started

Mar 2026

Finished

Jul 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 55 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.

Inclusion Criteria: * Participants with suitable veins for cannulation or repeated venipuncture. * All females must have a negative serum pregnancy test at the Screening Visit and on admission to the study site. * Females of childbearing potential must agree to use a highly effective contraception method from enrollment. * Male Participants, if heterosexually active, must practice true abstinence or use condoms during the trial and their female partners of childbearing potential must use additional effective contraception during the trial. * Body Mass Index (BMI) between 18 and 35 kg/m² and weigh at least 50 kg. Exclusion Criteria: * History of any clinically important disease or disorder which may put the participant at risk or influence the results, including: 1. Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper gastrointestinal (GI) tract 2. Cardiovascular disease 3. Neuromuscular or neurogenic disease 4. Type 1 or type 2 diabetes mellitus * History of acute pancreatitis, chronic pancreatitis, gallstones, or elevation in serum lipase/pancreatic amylase. * History of clinically significant cardiovascular, dermatological, respiratory, neurological, psychiatric or GI disease disorder. * History of malignant neoplastic disease. * History or presence of GI disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * Any clinically important illness, medical/surgical procedure, or trauma. * Any clinically important abnormalities in clinical chemistry, hematology, coagulation, or urinalysis results. * Basal calcitonin level ≥ 35 ng/L or history/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2). * Uncontrolled thyroid disease. * Any positive result on screening for serum human immunodeficiency virus (HIV). * Known or suspected history of alcohol or drug abuse or excessive intake of alcohol. * History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar chemical structure or class to AZD5004, or to mitiglinide and/or pioglitazone. * Participants who have previously received AZD5004.

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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

    Fukuoka, 813-0017, Japan

More trials for these conditions

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