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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00432068
First received: February 5, 2007
Last updated: February 16, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Healthy Cholecystectomized
Drug: Octreotide pamoate
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • Safety and tolerability assessed by physical exam, ecg, laboratory data and adverse event monitoring [ Time Frame: 48 hrs post study drug administration ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: January 2007
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Octreotide pamoate Drug: Octreotide pamoate

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432068

Locations
Belgium
Novartis Investigative Site
Ghent, Belgium
Novartis Investigative Site
Wavre-Gelgique, Belgium
France
Novartis Investigative Site
Lagord, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Rennes, France
Italy
Novartis Investigative Site
Verona, Italy
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00432068     History of Changes
Other Study ID Numbers: CSMS995K2101
Study First Received: February 5, 2007
Last Updated: February 16, 2011
Health Authority: France: Agence française de sécurité sanitaire des produits de santé (AFSSAPS)

Keywords provided by Novartis:
Healthy volunteers
octreotide pamoate
pharmacokinetics

Additional relevant MeSH terms:
Octreotide
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014