Investigating AZD5004's effects on various medications in healthy participants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I interventional study aims to evaluate how AZD5004 affects the pharmacokinetics of several medications, including rosuvastatin, atorvastatin, simvastatin, and repaglinide, as well as how erythromycin influences the pharmacokinetics of AZD5004. The study is structured into three independent parts, each focusing on different medication interactions. Healthy male and female participants aged 18 to 55 with a BMI between 20.0 and 35 kg/m2 will be enrolled. The study will involve multiple treatment periods and follow-up assessments to gather comprehensive data on drug interactions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Brooklyn, Maryland, United States Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.