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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Cholecystectomized
• Intervention / Treatment: Drug: Octreotide pamoate

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium
    • Novartis Investigative Site
  • Wavre-Gelgique, Belgium
    • Novartis Investigative Site
• France
  • Lagord, France
    • Novartis Investigative Site
  • Paris, France
    • Novartis Investigative Site
  • Rennes, France
    • Novartis Investigative Site
• Italy
  • Verona, Italy
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Octreotide pamoate	Drug: Octreotide pamoate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: February 5, 2007
• First Submitted That Met QC Criteria: February 5, 2007
• First Posted (Estimate): February 6, 2007

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 2, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Healthy volunteers; pharmacokinetics; octreotide pamoate
• Additional Relevant MeSH Terms: Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Octreotide
• Other Study ID Numbers: CSMS995K2101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO