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Donepezil

Phase 1

Alzheimer Disease | Small molecule | Neurology |Bristol-Myers Squibb Company|Last Updated: Jan 25, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

Donepezil · 1 trial · 1 indication

Phase 1 1
NCT01042314Drug-Drug Interaction Study With Aricept® (Donepezil)Alzheimer Disease
COMPLETED18 Analytics
PHASE1COMPLETED
Drug-Drug Interaction Study With Aricept® (Donepezil)
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Aricept® alone and with BMS-708163: Aricept® Multiple-dose pharmacokinetic parameters (Cmax, Tmax, AUC (TAU), and Ctrough) will be assessed without BMS-708163 on Day 14 and with BMS-708163 (Ctrough) on Day 28
Days 14 and 28

Secondary Endpoints

Aricept® alone and with BMS-708163: Safety and tolerability based on adverse events, ECG, vital signs and safety labs
Days 7, 14, 21, 29 and study discharge
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
Donepezil and BMS-708163EXPERIMENTAL -

Interventions

NameTypeDescription
DonepezilDRUGTablets, Oral, 5 mg, Once Daily, Days 1-28
BMS-708163DRUGCapsule, Oral, 125 mg, Once Daily, Days 15-28
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Healthy men and postmenopausal women Exclusion Criteria: * Medical History and Concurrent Diseases * Gastrointestinal disease * Gastrointestinal bleeding disorders * History of peptic ulcer disease * History of cholecystectomy * History of seizure disorder * History of asthm...

Countries:United States
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Frequently asked questions about Donepezil

What is Donepezil used for?

Donepezil is a small molecule being studied for the treatment of Alzheimer Disease. It is currently in Phase 1 clinical development as an investigational drug. The therapeutic area is Neurology, and the developer is Bristol-Myers Squibb Company (BMY).

Who makes Donepezil?

Donepezil is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The drug is a small molecule intended for Alzheimer Disease and is currently in Phase 1 clinical development.

What phase is Donepezil in?

Donepezil is in Phase 1 clinical development. It is an investigational drug for Alzheimer Disease and has not been approved by regulatory authorities. One Phase 1 trial has been completed, with no active trials currently ongoing.

What clinical trials is Donepezil in?

Donepezil has one completed clinical trial, NCT01042314, titled "Drug-Drug Interaction Study With Aricept® (Donepezil)". This Phase 1 study enrolled 18 participants with Alzheimer Disease in the United States. The trial was not randomized, double-blind, or controlled.

Is Donepezil the same as Aricept?

Yes, Donepezil is the same as Aricept. The clinical trial NCT01042314 is titled "Drug-Drug Interaction Study With Aricept® (Donepezil)", indicating that Aricept is a brand name for donepezil. The drug is being studied for Alzheimer Disease.