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Donepezil

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01042314Drug-Drug Interaction Study With Aricept® (Donepezil)PHASE1 COMPLETED 18Jan 1, 2010Apr 1, 2010Jan 25, 20111 United States
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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 — 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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