Open Label Study of a Single Dose of a New Extended Long Acting Formulation of Octreotide Pamoate in Healthy Volunteers
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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.
A Phase I , Open Label, Single Center, Dose Escalation Study to Assess the Pharmacokinetics, Safety and Tolerability of a Single Dose of a New Extended Long-acting Formulation of Octreotide Pamoate Administered i.m. in Healthy Cholecystectomized Volunteers
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
Resource links provided by the National Library of Medicine
Pharmacokinetics of a single dose of an extended long-acting formulation of octreotide pamoate [ Time Frame: 30min, 1, 2, 3, 4, 6, 8, 10, 12 and 24hrs post dose; Thereafter every 5 days for the first 40 days and every 7 days until study completion, 5 to 10 mins apart. ]
Safety and tolerability assessed by physical exam, ecg, laboratory data and adverse event monitoring [ Time Frame: 48 hrs post study drug administration ]
Secondary Outcome Measures :
To determine the relative bioavailability of a single dose of an extended long-acting formulation of octreotide pamoate [ Time Frame: 30min, 1, 2, 3, 4, 6, 8, 10, 12 and 24hrs post dose. Thereafter every 5 days for the first 40 days and every 7 days until study completion, 5 to 10 mins apart ]
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Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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