New drug interaction study launches in healthy volunteers
NCT ID NCT07444424
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 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.
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
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