Open Label Study of a Single Dose of a New Extended Long Acting Formulation of Octreotide Pamoate in Healthy Volunteers
- Registration Number
- NCT00432068
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Octreotide pamoate Octreotide pamoate -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Novartis Investigative Site
🇮🇹Verona, Italy