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GAP-134

Phase 1

Healthy Subjects | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 17, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00783341Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered IntravenouslyPHASE1 COMPLETED 25Nov 1, 2008Feb 1, 2009Jul 17, 20091 United States
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Study Endpoints
Primary Endpoints
Safety as determined by reported adverse events, laboratory test results, and ECGs
3 weeks
Secondary Endpoints
Pharmacokinetic parameters
9 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GAP-134EXPERIMENTAL -
placeboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
GAP-134DRUG -
placeboDRUG -
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion 1. Men or women of non childbearing potential (WONCBP) aged 18 to 50 years inclusive at screening. 2. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥50 kg. 3. Healthy as determined by the investigator on the basis of medical history, physical examination, clinic...

Countries:United States
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