Status:
COMPLETED
Open Label Study of a Single Dose of a New Extended Long Acting Formulation of Octreotide Pamoate in Healthy Volunteers
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Healthy Cholecystectomized
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00432068
Start Date
January 1 2007
End Date
June 1 2010
Last Update
December 3 2015
Active Locations (6)
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1
Novartis Investigative Site
Ghent, Belgium
2
Novartis Investigative Site
Wavre-Gelgique, Belgium
3
Novartis Investigative Site
Lagord, France
4
Novartis Investigative Site
Paris, France