A Study Investigating the Pharmacokinetics (PK) of a single dose administration of Cotadutide (MEDI0382)

Exclusion Criteria

• 1 History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, put the participant at risk, influence the participant's ability to participate, or affect interpretation of participant safety or study results.
• 2 Inflammatory bowel disease, gastroparesis or other severe disease or surgery affecting the upper gastrointestinal (GI) tract, which may affect gastric emptying or could affect the interpretation of safety and tolerability data.
• 3 Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2; eGFR will be determined by the chronic kidney disease - epidemiology collaboration (CKD-EPI) equation.
• 4 Blood pressure (BP) and heart rate in supine position outside the ranges of 90-140 mmHg systolic, 50-90 mmHg diastolic and heart rate 40-100 beats/min following a 10 minute rest period.
• 5 Active hepatitis B, measured by positive tests of serum hepatitis B surface antigen (HBsAg) and/or active hepatitis C, measured by positive hepatitis C virus antibody tests.
• 6 Positive human immunodeficiency virus (HIV) antibodies.
• 7 Participants with a history of acute or chronic pancreatitis.
• 8 Participants with a history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, and participants with a screening/baseline serum calcitonin ≥ 50 ng/L.
• 9 Signs or symptoms of severe hepatic impairment and any of the following laboratory values at screening: Aspartate transaminase (AST) ≥ 3 × upper limit of normal (ULN), alanine transaminase (ALT) ≥ 3 × ULN, or total bilirubin (TBL) ≥ 2 × ULN. Alternatively, AST ≥ 5 × ULN, ALT ≥ 5 × ULN, or TBL ≥ 2 × ULN regardless of signs and symptoms. An isolated increase in TBL in participants with known Gilbert’s syndrome is not a reason for exclusion.
• 10 Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss), a history of type 1 diabetes mellitus or diabetic ketoacidosis.
• 11 History of neoplastic disease within 5 years prior to screening except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
• 12 Known or suspected allergy to cotadutide, any component of the formulation, or related products.
• 13 Use of any prescription or nonprescription medication, with the exception of permitted concomitant medications, within the last 72 hours prior to Day 1.
• 14 History of alcoholism or drug abuse during the last 12 months.
• 15 Current smoker of cigarettes or other tobacco products.
• 16 Habitual excessive consumption of methylxanthine containing (theophylline, caffeine, or theobromine) beverages and foods (eg, coffee, tea, red bull, cola, chocolate) as judged by the investigator.
• 17 Blood donation within the last 3 months.
• 18 Participation in any other study investigating other products or involving blood sampling within the past 30 days.
• 19 Potentially noncompliant or uncooperative, as judged by the investigator.
• 20 Substance dependence likely to impact participant safety or compliance with study procedures, to include a positive test result for drugs of abuse and/or alcohol at screening or prior to administration of investigational product on Day 1.
• 21 Psychiatric illness such that participants have been committed to an institution by way of official or judicial order.
• 22 Involvement of any AstraZeneca, MedImmune, the contract research organization, or the study center employee or their close relatives.