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

NCT ID: NCT00432068

Last Updated: 2015-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2010-06-30

Brief Summary

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.

Conditions

Healthy Cholecystectomized

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Octreotide pamoate

Group Type: EXPERIMENTAL

Octreotide pamoate

Intervention Type: DRUG

Interventions

Octreotide pamoate

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmeceuticals

Locations

Novartis Investigative Site

Ghent, , Belgium

Novartis Investigative Site

Wavre-Gelgique, , Belgium

Novartis Investigative Site

Lagord, , France

Novartis Investigative Site

Paris, , France

Novartis Investigative Site

Rennes, , France

Novartis Investigative Site

Verona, , Italy

Countries

Belgium; France; Italy

Other Identifiers

CSMS995K2101

Identifier Type: -

Identifier Source: org_study_id