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SMC021

Phase 2

Health Postmenopausal Women | Small molecule | Other |Novartis AG|Last Updated: Jun 22, 2007

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00421590Drug Interaction of SMC021 With Concomitant Antacid (Calcium Carbonate/Magnesium Hydroxide).PHASE2 COMPLETED 38Oct 1, 2006 -Jun 22, 20071 Denmark
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Study Endpoints
Primary Endpoints
To assess the effect of concomitant antacid (calcium carbonate / magnesium hydroxide) on the pharmacokinetics and pharmacodynamics (decrease in serum CTX-I) of SMC021 (0.8 mg salmon calcitonin/200 mg 5-CNAC)
Secondary Endpoints
To assess the tolerability of concomitantly-administered antacid and SMC021
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
SMC021DRUG -
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Eligibility Criteria
Age Range40 Years — 70 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy postmenopausal female subjects, 40 to 70 years of age, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. * At Screening, and Baseline, vital signs (systolic and diastolic b...

Countries:Denmark
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