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PTH134

Phase 1

Postmenopausal Osteoporosis | Small molecule | Endocrine |Novartis AG|Last Updated: Dec 11, 2008

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 Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00676312Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effect of PTH134 at Increasing Doses in Healthy Postmenopausal SubjectsPHASE1 COMPLETED 32May 1, 2008 -Dec 11, 20081 Switzerland
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Study Endpoints
Primary Endpoints
•Safety and tolerability of ascending single doses of PTH134 over 24 hours as compared to baseline. •Pharmacokinetics after ascending single doses of PTH134, including comparison with reference drug Forteo 20 µg sc over 24 hours.
Secondary Endpoints
•Assessment of PK from PTH134 formulations over 24 hours. •Assessment of the pharmacodynamic profile of serum ionized calcium, total serum calcium, bone biomarkers with reference drug Forteo 20 µg and placebo over 24 hours.
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALCross-over treatment with increasing doses of PTH134, placebo and active comparator.
Interventions
NameTypeDescription
PTH134DRUG -
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Eligibility Criteria
Age Range40 Years — 70 Years
SexFEMALE
Healthy VolunteersNo
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 * Body mass index (BMI) within the range of 19 to 32. Exclusion Crit...

Countries:Switzerland
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