Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons

Subjects receive on separate days, in random order one of the following: 1 mg BIOD-961 intramuscularly (IM), 1 mg Lilly (IM), 1 mg Novo (IM), 1 mg BIOD-961 subcutaneously (SC), 1 mg Lilly (SC), and 1 mg Novo (SC).

Inclusion criteria

• Body Mass Index: 18.5-25.0 kg/m2 inclusive.
• Subject has provided informed consent and has signed and dated an informed consent form before any trial-related activities.

Exclusion criteria

• Type 1 or type 2 diabetes mellitus.
• History of pheochromocytoma, insulinoma, glucagonoma, or glycogen storage disease.
• History of regular alcohol consumption as defined by alcohol intake exceeding 7 drinks per week for females or 14 drinks per week for males, where 1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor.
• Significant cardiovascular (to include New York Heart Association (NYHA) Class III or- IV functional capacity or uncontrolled hypertension), respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease.
• Any significant cardiovascular event history, including angina, myocardial infarction, therapeutic coronary procedure (e.g, percutaneous transluminal coronary angioplasty, coronary bypass surgery), stroke, or transient ischemic attack.
• Females who are breast feeding, pregnant, or intending to become pregnant during the study.