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PPM-204

Phase 1

Diabetes Mellitus | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Dec 5, 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-BlindUNCONTROLLED
Total Trials2
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00447629Study Evaluating Single Doses of PPM-204 on the Electrical Pathways of the HeartPHASE1 COMPLETED -Jan 1, 2007Mar 1, 2007Dec 5, 20071 United States
NCT00448032Study Evaluating Multiple Oral Doses of PPM-204 in Healthy Japanese Male SubjectsPHASE1 COMPLETED -Nov 1, 2006Mar 1, 2007Dec 5, 20071 Japan
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Study Endpoints
Primary Endpoints
Safety
Secondary Endpoints
Pharmacokinetics
Pharmacokinetics/Pharmacodynamics
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeDIAGNOSTIC
Interventions
NameTypeDescription
PPM-204DRUG -
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Men or women, aged 18 to 55 years * Body mass index in the range of 18 to 30 kg/m2 * Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG Exclusion Criteria: * History ...

Countries:United StatesJapan
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