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SAM-531

Phase 2

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

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

Clinical trial landscape

SAM-531 · 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

What is SAM-531 used for?

SAM-531 is an investigational small molecule being studied for Alzheimer Disease. It has been evaluated in healthy volunteers and in patients with Alzheimer Disease across multiple clinical trials. The drug is currently in Phase 2 development and is not approved by the FDA.

Who makes SAM-531?

SAM-531 is being developed by Pfizer, Inc., a company listed on the New York Stock Exchange under the ticker symbol PFE. Pfizer has sponsored multiple clinical trials of SAM-531 in healthy subjects and in patients with Alzheimer Disease.

What phase is SAM-531 in?

SAM-531 is in Phase 2 clinical development. It has completed eight clinical trials, including Phase 1 studies, with a total enrollment of 412 participants. The drug remains investigational and has not received regulatory approval.

What clinical trials has SAM-531 been in?

SAM-531 has completed eight clinical trials. Notable studies include NCT00479297 in healthy Japanese males, NCT00519298 on sleep EEG in healthy subjects, NCT00745576 on interaction with verapamil, and NCT00966966 on interaction with gemfibrozil. All trials are completed, with no active trials ongoing.

Is SAM-531 the same as any other drug?

SAM-531 is the primary name used in clinical trial records for this investigational drug. No alternative names have been associated with SAM-531 in the available trial data. It is a distinct small molecule being studied for Alzheimer Disease.

How is SAM-531 studied in clinical trials?

SAM-531 has been studied in randomized, double-blind, active-controlled trials. These trials included both healthy volunteers and patients with Alzheimer Disease, with a focus on safety, tolerability, pharmacokinetics, and pharmacodynamics. The studies were not biomarker-selected.