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salmon calcitonin

Phase 1

Postmenopausal Osteoporosis | Small molecule | Endocrine |Novartis AG|Last Updated: Dec 13, 2006

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
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment86
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00411125Pharmacokinetics and Pharmacodynamics Study of Oral Salmon Calcitonin in Healthy Postmenopausal WomenPHASE1 COMPLETED 86 — — Aug 1, 2006Nov 1, 2006Dec 13, 20061 Denmark
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Study Endpoints
Primary Endpoints
Pharmacokinetic profile of the new variant compared to the current variant on Day 1
Effect on bone resorption biomarker on Day 1
Secondary Endpoints
Effect on bone resorption biomarker 24 hours after the last dosing on Day 3
Effect on bone resorption biomarker after drug intake at different timepoints
Effect of dosing at different timepoints on the pharmacokinetic profile
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
Oral salmon calcitoninDRUG -
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Eligibility Criteria
Age Range40 Years — 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Healthy postmenopausal women Exclusion Criteria: * Previous treatment with other osteoporosis medication Other protocol-defined inclusion/exclusion criteria may apply.

Countries:Denmark
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