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Dimebon IR

Phase 1

Alzheimer's Disease | Small molecule | Neurology |Pfizer, Inc.|Last Updated: Feb 3, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

Dimebon IR · 2 trials · 3 indications

Phase 1 2
NCT00988624A Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine)Alzheimer's Disease
COMPLETED20 Analytics
NCT00990613A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The SkinAlzheimer's Disease
COMPLETED19 Analytics
PHASE1COMPLETED
A Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine)
Alzheimer's DiseaseUnlock trial analytics
PHASE1COMPLETED
A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The Skin
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

PK endpoints for dimebon and M7 (where appropriate) for each formulation: AUC0-24, AUC0-24(dn), AUCinf (as data permit) AUCinf(dn), AUClast, AUClast(dn), Tlag, Cmax, Tmax, and t1/2 (as data permit).
Day 1-3 of Period 1, 2, 3, 4, or 5
Pharmacokinetic endpoints include dimebon area under the curve from 0 to the last quantifiable concentration (AUClast) and dimebon area under the curve from 0 to infinity (AUCinf) as permitted by data
4 to 6 days

Secondary Endpoints

Safety and tolerability for each formulation (AEs, ECG, vital signs, safety labs)
Day 1-3 of Period 1, 2, 3, 4, or 5
Safety endpoints include subjective symptoms/objective findings (including skin irritation), clinical safety laboratory assessments, 12 lead ECGs, and supine vital signs.
4 to 6 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Period 1EXPERIMENTAL -
Period 2EXPERIMENTAL -
Period 3EXPERIMENTAL -
Period 4EXPERIMENTAL -
Period 5EXPERIMENTAL -
Cohort 1OTHER -
Cohort 2OTHER -

Interventions

NameTypeDescription
Dimebon IR TabletDRUGPharmacokinetics of a single oral dose of 10 mg dimebon immediate release tablet will be assessed on Day 1 - 3.
Dimebon MR1DRUGPharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR1, will be assessed on Day 1 - 3.
Dimebon MR2DRUGPharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR2, will be assessed on Day 1 - 3.
Dimebon MR3DRUGPharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR3, will be assessed on Day 1 - 3.
Dimebon MR4DRUGPharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR4, will be assessed on Day 1 - 3.
Dimebon IRDRUGA single, oral 10 mg dose of dimebon dihydrochloride (equivalent to 8.2 mg free base) immediate release will be administered.
Dimebon TransdermalDRUGA single, transdermal 5 mg dose of dimebon free base solution will be applied to the back over a 24 hour period. A double-blinded vehicle (placebo) solution will be applied concurrently to a contralateral body site.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, p...

Countries:United States
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Frequently asked questions about Dimebon IR

What is Dimebon IR used for?

Dimebon IR is an investigational small molecule being developed for Alzheimer's Disease. It is in Phase 1 clinical development, meaning it has not been approved by the FDA and is still being studied in clinical trials.

Who makes Dimebon IR?

Dimebon IR is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's pharmacokinetics and absorption in healthy volunteers.

What phase is Dimebon IR in?

Dimebon IR is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA and is still being studied in clinical trials. Two Phase 1 trials have been completed, with no active trials currently ongoing.

What clinical trials is Dimebon IR in?

Dimebon IR has been studied in two completed Phase 1 clinical trials. NCT00988624 evaluated the pharmacokinetics of four modified-release formulations in 20 healthy volunteers, and NCT00990613 evaluated the absorption of a Dimebon solution applied to the skin in 19 healthy volunteers. Both trials were conducted in the United States.

Is Dimebon IR the same as Latrepirdine?

Yes, Dimebon IR is also known as Latrepirdine. The clinical trials for Dimebon IR refer to it as Dimebon (Latrepirdine), indicating that these names refer to the same investigational drug being developed by Pfizer.