Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-01 @ 9:09 AM
Study NCT ID:
NCT00432068
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2007-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label Study of a Single Dose of a New Extended Long Acting Formulation of Octreotide Pamoate in Healthy Volunteers
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: