Autoinjector Device Assessment Study - BCB119

Exclusion Criteria

• - Has a clinically significant medical condition that could potentially affect study participation and/or
• personal well-being, as judged by the investigator, including but not limited to the following
• conditions:
• a. History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations
• ≥500 mg/dL at Visit 1 (Screening)
• b. Presence of medullary carcinoma or multiple endocrine neoplasia (MEN II) OR a family history
• of medullary carcinoma or MEN II
• c. Organ transplantation
• d. Active cardiovascular disease within 3 months of Visit 1 such as myocardial infarction, clinically
• significant arrhythmia, unstable angina, coronary artery bypass surgery, or angioplasty; or are
• expected to require coronary artery bypass surgery or angioplasty during the course of the
• study. Subjects with stable cardiac disease are not excluded.
• e. Presence or history of severe congestive heart failure (New York Heart Association Class IV
• [CCNYHA 1994])
• f. Central nervous system disease, including epilepsy (individuals with a history of convulsions
• associated with hypoglycemia will not be excluded)
• g. Liver disease, acute or chronic hepatitis, alanine aminotransaminase (ALT), or serum glutamic
• pyruvic transaminase (SGPT) greater than 3 times the upper limit of the reference range
• h. History or presence of inflammatory bowel disease or other severe gastrointestinal diseases,
• particularly those which may impact gastric emptying, such as gastroparesis, pyloric stenosis,
• gastric bypass surgery or gastric banding surgery
• i. Clinically significant malignant disease (with the exception of basal and squamous cell
• carcinoma of the skin) within 5 years of Visit 1 (Screening)
• j. Hemoglobinopathy, hemolytic anemia, or anemia (hemoglobin concentration below the lower
• limit of normal unless deemed not clinically significant by the investigator)
• k. Two or more episodes of severe hypoglycemia within 6 months prior to Visit 1. Refer to Section
• 9.1.5.2 for more information on hypoglycemia
• l. Evidence of acute or chronic illness including known or suspected human immunodeficiency
• virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) infection
• - Has any abdominal skin abnormalities (e.g., extensive scarring, burns, inflammation,
• hyperkeratosis, etc.) which, in the investigator’s opinion, could interfere with the injection.
• - Has serum calcitonin concentration ≥100 pg/mL at Visit 1 (Screening)
• - Has evidence of current abuse of drugs or alcohol or a history of abuse that, in the investigator’s
• opinion, would cause the individual to be noncompliant
• - Has a positive urine drug screen (including screen for cocaine, opiates, amphetamines, and
• cannabinoids)
• - Has received any investigational drug within 30 days (or 5 half-lives of the investigational drug,
• whichever is greater) prior to Visit 1 (Screening)
• - Has donated blood or had a significant blood loss within 2 months of first dose of study drug or is
• planning to donate blood during the study
• - Has had a major surgery or a blood transfusion within 2 months prior to Visit 1 (Screening)
• - Has known contraindication, allergies, or hypersensitivity to any component of study drug
• (including poly-D,L lactide co-glycolide [PLG] and MCT)
• - Is employed by Amylin, Alkermes, Bristol-Myers Squibb, or AstraZeneca (i.e. that is an employee,
• temporary contract worker, or designee responsible for the conduct of the study)