Status:
COMPLETED
A Study to Investigate the Effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the Effect of Erythromycin on AZD5004 in Healthy Participants
Lead Sponsor:
AstraZeneca
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study will assess the effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the effect of Erythromycin on AZD5004 in healthy adult male and female participants.
Detailed Description
This is a Phase I, open-label, fixed-sequence, single center study which consists of 3 parts: Part A, Part B and Part C. Part A, Part B, and Part C are 3 independent and non-sequential parts in this s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2025
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT06948747
Start Date
May 6 2025
End Date
October 3 2025
Last Update
October 10 2025
Active Locations (1)
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1
Research Site
Brooklyn, Maryland, United States, 21225