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Vatalinib

Phase 1

Healthy | Small molecule | Other |Novartis AG|Last Updated: Nov 19, 2009

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00426452A Drug-drug Interaction Study of Oral 1250 mg of Vatalinib Administered Under Fasting and Fed Conditions With a Proton-pump Inhibitor in Healthy Sterile or Postmenopausal Female VolunteersPHASE1 COMPLETED 24Jul 1, 2006 -Nov 19, 2009 -
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Study Endpoints
Primary Endpoints
Assess the effect of multiple doses of a proton-pump inhibitor on the pharmacokinetics of a single dose of Vatalinib under fasting and fed conditions.
Secondary Endpoints
Safety of a single dose of Vatalinib before and after a proton-pump inhibitor under fasting and fed conditions as assessed by adverse events, laboratory values, electrocardiograms, and vital signs.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
VatalinibDRUG -
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Eligibility Criteria
Age Range35 Years — 70 Years
SexFEMALE
Healthy VolunteersNo

Inclusion criteria * Healthy female * Surgically sterile or post-menopausal * At least a weight of 50 kg and have a body mass index (BMI) ≤33.0 * Non-smokers or those who smoke 25 cigarettes or less per day Exclusion criteria * Use of certain prescription and over the counter drugs * Having receive...

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