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AHT956

Phase 1

Healthy | 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 Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00410228Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AHT956 in Healthy SubjectsPHASE1 COMPLETED 42 — — Jun 1, 2006 -Jun 22, 20071 Switzerland
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Study Endpoints
Primary Endpoints
Safety, tolerability of ascending single doses of AHT956 in healthy subjects
MTD (Maximum Tolerated Dose)
Secondary Endpoints
Pharmacokinetics of single oral doses of AEB071
Inhibition of T-cell function and lymphocytes proliferation following single rising oral of AHT956
Pharmacokinetic/pharmacodynamic relationship of single rising oral doses of AHT956 at the end of study
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
AHT956DRUG -
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female subjects age 18 to 45 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. * Vital signs must be within the following ranges: oral body ...

Countries:Switzerland
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