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Octreotide pamoate

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00432068Open Label Study of a Single Dose of a New Extended Long Acting Formulation of Octreotide Pamoate in Healthy VolunteersPHASE1 COMPLETED 48 — — Jan 1, 2007Jun 1, 2010Dec 3, 20156 Belgium, France +1
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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 — 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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