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GSI 136

Phase 1

Alzheimer Disease | Small molecule | Neurology |Pfizer, Inc.|Last Updated: Apr 2, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment152

FDA Designations

No designations recorded

Clinical trial landscape

GSI 136 · 2 trials · 2 indications

Phase 1 2
NCT00718731Study GSI-136 in Healthy Young and Healthy Elderly SubjectsAlzheimer Disease
COMPLETED80 Analytics
NCT00719394Study Evaluating Safety of GSI 136 in Young and Elderly Japanese MalesAlzheimer Disease
COMPLETED72 Analytics
PHASE1COMPLETED
Study GSI-136 in Healthy Young and Healthy Elderly Subjects
Alzheimer DiseaseUnlock trial analytics
PHASE1COMPLETED
Study Evaluating Safety of GSI 136 in Young and Elderly Japanese Males
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of GSI-136 as evaluated from reported adverse events, scheduled physical examinations, vital sign measurements, orthostatic vital sign measurements, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results.
6 months

Secondary Endpoints

Pharmacokinetics as evaluated from the blood and urine concentrations of GSI-136; Pharmacodynamics as evaluated from the levels of select biomarkers in the blood and the administration of a visual analog scale to measure sedation effects.
6 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALSubject on active drug
2PLACEBO_COMPARATORSubject on placebo
GSI 136EXPERIMENTAL -
placeboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
GSI-136DRUG -
PlaceboOTHER -
GSI 136DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

\<Inclusion: 1. Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years or greater than 65 years, inclusive, at screening. WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for greater than 1 year (with follicle-stimulat...

Countries:United StatesJapan
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Frequently asked questions about GSI 136

What is GSI 136 used for?

GSI 136 is an investigational small molecule being developed by Pfizer for Alzheimer Disease. It is currently in Phase 1 clinical development, meaning it is still being tested in early-stage trials and is not yet approved for use.

Who makes GSI 136?

GSI 136 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting Phase 1 clinical trials to evaluate the safety and tolerability of the drug in healthy volunteers.

What phase is GSI 136 in?

GSI 136 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers, with a total enrollment of 152 participants. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is GSI 136 in?

GSI 136 has been studied in two completed Phase 1 trials: NCT00718731, which enrolled 80 healthy young and elderly subjects in the United States, and NCT00719394, which enrolled 72 healthy young and elderly Japanese males in Japan. Both trials were randomized, double-blind, and placebo-controlled.

Is GSI 136 the same as GSI-136?

Yes, GSI 136 and GSI-136 refer to the same investigational drug. The clinical trial NCT00718731 uses the name GSI-136, while NCT00719394 uses GSI 136. Both trials are Phase 1 studies sponsored by Pfizer in healthy volunteers.