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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 December 2015
• Main ID: NCT00432068
• Date of registration: 05/02/2007
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Open Label Study of a Single Dose of a New Extended Long Acting Formulation of Octreotide Pamoate in Healthy Volunteers
• Scientific 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
• Date of first enrolment: January 2007
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00432068
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Belgium, France, Italy

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmeceuticals

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Cholecystectomized

Intervention(s)

Drug: Octreotide pamoate

Primary Outcome(s)

Safety and tolerability assessed by physical exam, ecg, laboratory data and adverse event monitoring [Time Frame: 48 hrs post study drug administration]

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.]

Secondary Outcome(s)

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]

Secondary ID(s)

CSMS995K2101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors