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SAM-531 and gemfibrozil

Phase 2

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

SAM-531 and gemfibrozil development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Aug 2009

SAM-531 and gemfibrozil target and mechanism

ModalitySmall molecule

Also known as SAM-531

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials8
Total Enrollment412

FDA Designations

No designations recorded

SAM-531 and gemfibrozil clinical trials

SAM-531 and gemfibrozil · 8 trials · 1 indication

Phase 2 1Phase 1 7
NCT00481520Study Evaluating the Safety,Tolerability, PK and PD of SAM-531 in the Subjects With Mild to Moderate Alzheimer's DiseaseAlzheimer Disease
COMPLETED72 Analytics
PHASE2COMPLETED
Study Evaluating the Safety,Tolerability, PK and PD of SAM-531 in the Subjects With Mild to Moderate Alzheimer's Disease
Alzheimer DiseaseUnlock trial analytics

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 to 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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Frequently asked questions about SAM-531 and gemfibrozil

What is SAM-531 used for in Alzheimer Disease?

SAM-531 is an investigational small molecule that was studied as a treatment for Alzheimer Disease. It was developed by Pfizer and reached Phase 2 clinical development. All eight of its registered trials have been completed, and no trials are currently active. It is not described as an approved therapy for Alzheimer Disease.

Who makes SAM-531?

SAM-531 was developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical program evaluating the compound in Alzheimer Disease, including Phase 1 pharmacokinetic and drug interaction studies and a Phase 2 study in patients with mild to moderate disease.

What phase is SAM-531 in?

SAM-531 reached Phase 2 clinical development for Alzheimer Disease. Eight trials have been registered in total, all of which are completed, and none are currently active. The program includes Phase 1 studies in healthy volunteers and a Phase 2 study in patients with mild to moderate Alzheimer Disease.

What clinical trials is SAM-531 in?

SAM-531 has been studied in eight completed trials, including NCT00906191, a Phase 1 absorption, metabolism and elimination study in the Netherlands; NCT00745576, a Phase 1 verapamil interaction study in France; NCT00726115, a Phase 1 single and multiple dose study in France; and NCT00481520, a Phase 2 study in mild to moderate Alzheimer Disease in the United States.