AZD5004 drug interaction study: no cure, just data
NCT ID NCT06948747
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how a new drug called AZD5004 affects the way the body processes several common medicines, including statins (for cholesterol) and repaglinide (for diabetes), in healthy adults aged 18 to 55. It also checked how another drug, erythromycin, affects AZD5004. The goal was simply to gather safety and interaction information, not to treat any disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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49 people
The number who actually took part.
- Started
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May 2025
- Finished
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Oct 2025
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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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: * Healthy male and female participants aged 18 to 55 years * All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit. * Female(s) of childbearing potential if heterosexually active, must agree to use an approved method of highly effective contraception. * Male participants must use condoms for the duration of clinical trial. * Additional contraception must be used for the sexual partners of male trial participants throughout the clinical trial. * Have a body mass index (BMI) between ≥ 20.0 and ≤ 35 kg/m2 (at the time of screening) inclusive and weigh at least 50 kg. Exclusion Criteria: * History of any clinically important disease or disorder (liver transplant, liver disease, positive for serum HBsAg (Hepatitis B surface antigen) OR anti-HBcAb (Hepatitis B core antibody), positive for anti-HCV (Hepatitis C virus), history of cirrhosis and/or hepatic decompensation, cardiovascular disease, neuromuscular or neurogenic disease. * History of Type 1 or Type 2 diabetes mellitus (DM). * History of Hemoglobin A1c ≥ 6.5% (≥ 48 mmol/mol) at screening. * History or presence of gastrointestinal, hepatic, or renal 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 laboratory values with deviations or clinically important abnormalities in clinical chemistry, hematology, or urinalysis at the Screening Visit or on admission to the Clinical Unit. * Significant hepatic disease as judged by the investigator. * Any positive result on screening for serum HBsAg, HBcAb or HIV (Human immunodeficiency virus). * Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12 lead ECG, at screening * Abnormal vital signs. * Uncontrolled thyroid disease or history/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2). * Current smokers or those who have smoked or used nicotine products. * Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the investigator. Excessive intake of alcohol defined as the regular consumption of more than 24 g of alcohol per day for men or 12 g of alcohol per day for females. * Positive screen for drugs of abuse, or alcohol or cotinine at screening or on each admission to the Clinical Unit. * History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity. * Excessive intake of caffeine-containing drinks or food * History of psychosis or bipolar disorder or major depressive disorder or suicide attempt or suicidal ideation.
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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
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Research Site
Brooklyn, Maryland, 21225, United States
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Other studies related to the condition(s) this trial covers.
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