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SAM-531

Phase 2

Alzheimer Disease | Small molecule | Neurology |Pfizer, Inc.|Last Updated: Feb 8, 2010

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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials8
Total Enrollment412
FDA Designations
No designations recorded
Clinical Trials (8)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00481520Study Evaluating the Safety,Tolerability, PK and PD of SAM-531 in the Subjects With Mild to Moderate Alzheimer's DiseasePHASE2 COMPLETED 72Jun 1, 2007Jan 1, 2008Sep 30, 20097 United States
NCT00906191Study Evaluating How Quickly And To What Extent The 14-Carbon-SAM-531 Is Absorbed/Converted/Eliminated In Male SubjectsPHASE1 COMPLETED 6May 1, 2009Aug 1, 2009Aug 26, 20091 Netherlands
NCT00745576Study Evaluating The Potential Interaction Between Verapamil Immediate Release And SAM-531 When Co-AdministeredPHASE1 COMPLETED 14Oct 1, 2008Dec 1, 2008Feb 8, 20101 France
NCT00726115Study Evaluating Safety, Tolerability and Pharmacokinetics of Single and Multiple Dose of SAM-531PHASE1 COMPLETED 56Aug 1, 2008Feb 1, 2009Jul 30, 20091 France
NCT00479349Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531PHASE1 COMPLETED 32May 1, 2007Jan 1, 2008Jul 7, 20091 Japan
NCT00480818Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Young and Elderly SubjectsPHASE1 COMPLETED 80Sep 1, 2006Jul 1, 2007Dec 11, 20071 France
NCT00479297Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Japanese MalesPHASE1 COMPLETED 72May 1, 2006Feb 1, 2007Aug 7, 2009 -
NCT00479700Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy SubjectsPHASE1 COMPLETED 80May 1, 2006Jul 1, 2006Dec 10, 2007 -
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Study Endpoints
Primary Endpoints
Routine safety and tolerability will be evaluated.
28 days
Radioactivity measurements in blood, urine and feces and pharmacokinetic parameters (Cmax, AUC, terminal elimination half life, total clearance and volume of distribution in the plasma ; urine clearance ; metabolite profiling in plasma, urine and feces.)
15 days
blood samples
7 weeks
Pharmacokinetics, routine Lab tests, Vital signs, ECG
29 days
Safety and tolerability
9 months
Secondary Endpoints
This study will also investigate the pharmacokinetics(PK, how the drug is metabolized) and pharmacodynamics (PD, how the drug affects bodily and mental function) of SAM-531 compared to placebo.
28 days
Safety based on supine vital signs evaluations, 12-lead ECGs and routine lab tests
7 weeks
Pharmacokinetics and pharmacodynamics
9 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
SAM-531DRUG -
placeboOTHER -
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Eligibility Criteria
Age Range50 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria 1. Signed and dated written informed consent obtained from the subject or the subject's legally authorized representative (LAR) or next of kin (if applicable), in accordance with the local regulations. The subject's caregiver must also consent to participate in the study. 2. Diag...

Countries:United StatesNetherlandsFranceJapan
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