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

NCT00432068 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2015-12-03

No results posted yet for this study

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.

Conditions

  • Healthy Cholecystectomized

Interventions

DRUG

Octreotide pamoate

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmeceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Belgium
  • France
  • Italy

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00432068 on ClinicalTrials.gov