Open Label Study of a Single Dose of a New Extended Long Acting Formulation of Octreotide Pamoate in Healthy Volunteers

Inclusion criteria:

• Male or female from 18-60 years of age, cholecystectomized at least 4 months prior to the start of the study.
• In a good health as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests at screening
• Body mass index within 19-29 kg/m2
• Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion criteria:

• Any clinically significant abnormal laboratory values at screening, or evidence of clinically significant abnormal findings at the physical exam at screening, or significant illness within 2 weeks prior to dosing
• A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome
• History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or untreated)
• History of clinically significant drug allergy, history of atopic allergy, history or clinical evidence of pancreatic injury or pancreatitis, clinical evidence of liver disease or liver injury , history or presence of impaired renal function, or history of urinary obstruction or difficulty urinating
• History of immunocompromise, including a positive HIV
• Known positive hepatitis B or C surface antigen (HBsAg) or Hepatitis C test result (anti-HCV)
• History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays at screening
• Female subjects who are pregnant or lactating, or are of childbearing potential and without a medically acceptable and highly effective method for birth control.
• Demonstrating intolerance to octreotide at baseline
• Any subject who has a known history of diabetes mellitus in parents or grandparents.

Other protocol-defined inclusion/exclusion criteria may apply