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Octreotide pamoate

Phase 1

Healthy Cholecystectomized | Small molecule | Other |Novartis AG|Last Updated: Dec 3, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

Octreotide pamoate · 1 trial · 1 indication

Phase 1 1
NCT00432068Open Label Study of a Single Dose of a New Extended Long Acting Formulation of Octreotide Pamoate in Healthy VolunteersHealthy Cholecystectomized
COMPLETED48 Analytics
PHASE1COMPLETED
Open Label Study of a Single Dose of a New Extended Long Acting Formulation of Octreotide Pamoate in Healthy Volunteers
Healthy Cholecystectomized
NCT0043206848
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Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Octreotide pamoateEXPERIMENTAL -

Interventions

NameTypeDescription
Octreotide pamoateDRUG -
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites6

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 with...

Countries:BelgiumFranceItaly
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Frequently asked questions about Octreotide pamoate

What is Octreotide pamoate used for?

Octreotide pamoate is an investigational small molecule being studied in healthy cholecystectomized volunteers. It is a new extended long acting formulation of octreotide pamoate, evaluated in a Phase 1 clinical trial. The drug is not approved and remains in clinical development.

Who makes Octreotide pamoate?

Octreotide pamoate is being developed by Novartis AG, traded on the New York Stock Exchange under the ticker NVS. The company is conducting clinical research on this extended long acting formulation of octreotide pamoate.

What phase is Octreotide pamoate in?

Octreotide pamoate is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The single Phase 1 trial has been completed, and the drug remains under investigation.

What clinical trials is Octreotide pamoate in?

Octreotide pamoate has one completed clinical trial, NCT00432068, titled "Open Label Study of a Single Dose of a New Extended Long Acting Formulation of Octreotide Pamoate in Healthy Volunteers." This Phase 1 study enrolled 48 participants in Belgium, France, and Italy.

Is Octreotide pamoate the same as octreotide?

Octreotide pamoate is a specific extended long acting formulation of octreotide. The clinical trial evaluates a single dose of this new formulation in healthy volunteers who have undergone cholecystectomy. It is distinct from other octreotide formulations.