Phase
Condition
N/ATreatment
Erythromycin
Rosuvastatin
AZD5004
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 onadmission to the Clinical Unit.
Female(s) of childbearing potential if heterosexually active, must agree to use anapproved 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 trialparticipants throughout the clinical trial.
Have a body mass index (BMI) between ≥ 20.0 and ≤ 35 kg/m2 (at the time ofscreening) inclusive and weigh at least 50 kg.
Exclusion
Exclusion Criteria:
History of any clinically important disease or disorder (liver transplant, liverdisease, positive for serum HBsAg (Hepatitis B surface antigen) OR anti-HBcAb (Hepatitis B core antibody), positive for anti-HCV (Hepatitis C virus), history ofcirrhosis and/or hepatic decompensation, cardiovascular disease, neuromuscular orneurogenic 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 othercondition known to interfere with absorption, distribution, metabolism, or excretionof drugs.
Any clinically important illness, medical/surgical procedure, or trauma.
Any laboratory values with deviations or clinically important abnormalities inclinical chemistry, hematology, or urinalysis at the Screening Visit or on admissionto the Clinical Unit.
Significant hepatic disease as judged by the investigator.
Any positive result on screening for serum HBsAg, HBcAb or HIV (Humanimmunodeficiency virus).
Any clinically important abnormalities in rhythm, conduction, or morphology of theresting 12 lead ECG, at screening
Abnormal vital signs.
Uncontrolled thyroid disease or history/family history of medullary thyroidcarcinoma (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 alcoholas judged by the investigator. Excessive intake of alcohol defined as the regularconsumption of more than 24 g of alcohol per day for men or 12 g of alcohol per dayfor females.
Positive screen for drugs of abuse, or alcohol or cotinine at screening or on eachadmission to the Clinical Unit.
History of severe allergy/hypersensitivity or ongoing clinically importantallergy/hypersensitivity.
Excessive intake of caffeine-containing drinks or food
History of psychosis or bipolar disorder or major depressive disorder or suicideattempt or suicidal ideation.
Study Design
Study Description
Connect with a study center
Research Site
Brooklyn, Maryland 21225
United StatesActive - Recruiting
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