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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Cholecystectomized

Intervention / Treatment
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* Drug: Octreotide pamoate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Octreotide pamoate<br> | Drug: Octreotide pamoate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of a single dose of an extended long-acting formulation of octreotide pamoate |  | 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 |  | 48 hrs post study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the relative bioavailability of a single dose of an extended long-acting formulation of octreotide pamoate |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers, octreotide pamoate, pharmacokinetics