Open Label Study of a Single Dose of a New Extended Long Acting Formulation of Octreotide Pamoate in Healthy Volunteers
Open Label Study of a Single Dose of a New Extended Long Acting Formulation of Octreotide Pamoate in Healthy Volunteers
This study will assess the pharmacokinetic profile, safety and tolerability of an octreotide
 extended long-acting formulation after a single dose in humans. It will investigate the
 profile of a single dose of drug in a healthy volunteer subject in order to understand the
 timing and extent of fluctuations in octreotide concentrations in the blood with this
 formulation, the relationship of drug concentration with dose, and how long the drug remains
 in the body system.
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