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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00432068
Recruitment Status : Completed
First Posted : February 6, 2007
Last Update Posted : December 3, 2015
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Healthy Cholecystectomized Drug: Octreotide pamoate Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 : January 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Octreotide pamoate Drug: Octreotide pamoate

Primary Outcome Measures :
  1. 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. ]
  2. 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 :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00432068

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
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00432068     History of Changes
Other Study ID Numbers: CSMS995K2101
First Posted: February 6, 2007    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Healthy volunteers
octreotide pamoate

Additional relevant MeSH terms:
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents