Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- * All participants must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- * Women of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception.
- * Females of non-childbearing potential must be confirmed at the Screening Visit.
- * Have a Body Mass Index (BMI) ≥ 25 kg/m2 inclusive and weigh at least 60 kg.
- * History of any clinically important disease or disorder (gastroparesis, deep vein thrombosis, previous surgery of the upper gastrointestinal tract, cardiovascular disease, neuromuscular or neurogenic disease, severe vitamin D deficiency, type I or type II diabetes mellitus, glycated hemoglobin (HbA1c) ≥ 6.5%) 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.
- * Any positive result on screening for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb) or Human immunodeficiency virus (HIV).
- * Abnormal vital signs.
- * Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12 lead electrocardiogram (ECG), at screening.
- * 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.
- * History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
- * Statin treatment within 4 weeks prior to the start of study treatment.
- * Current use of estrogen-containing products.
Ages Eligible for Study
35 Years to 75 Years
Sexes Eligible for Study
FEMALE
Accepts Healthy Volunteers
Yes