Investigating AZD5004's effects on various medications in healthy participants
An Open-label, Fixed-sequence, Three-part Study to Assess the Effect of AZD5004 on the Pharmacokinetics of Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and to Assess the Effect of Erythromycin on AZD5004 in Healthy Participants
This study is testing how a new drug called AZD5004 interacts with other medications in healthy adults to see how it affects their absorption and effectiveness.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 1 site (Brooklyn, Maryland) |
| Trial ID | NCT06948747 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 55 with a BMI between 20.0 and 35 kg/m2.
Not a fit: Patients with a history of clinically important diseases or disorders, such as liver disease or cardiovascular conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of drug interactions, leading to safer and more effective medication regimens for patients.
How similar studies have performed: While this study explores specific drug interactions, similar pharmacokinetic studies have shown success in understanding medication effects, making this approach both relevant and valuable.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Brooklyn, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.