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galantamine

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
ACTIVE_CONTROLLED
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01039194Drug-Drug Interaction to Study the Effect of BMS-708163 on Pharmacokinetics (PK) of Galantamine Extended Release (ER)PHASE1 COMPLETED 18Jan 1, 2010Apr 1, 2010Jan 25, 20111 United States
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Study Endpoints
Primary Endpoints
Galantamine alone and with BMS-708163: Galantamine PK parameters (Cmax, Tmax, AUC(TAU) and Ctrough rations will be assessed without BMS-708163 Day 14) and with BMS708-163 (Ctrough Day 24)
Study Days 14 & 24
Secondary Endpoints
Galantamine alone and with BMS 708163: Safety and tolerability (AE's, ECG, vital signs, safety labs)
Study Days 7, 14, 18, 25 and study discharge
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
galantamine 8 mg (ER)ACTIVE_COMPARATOR -
galantamine 16 mg (ER)ACTIVE_COMPARATOR -
BMS-708163ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
galantamineDRUGCapsule, Oral, 8 mg (ER), once daily, Days 1-7
BMS-708163DRUGCapsule, Oral, 125 mg, once daily, Days 15-24
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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: * Gastrointestinal disorders * Bleeding disorders * Peptic ulcer disease * Cholecystectomy * Seizure disorder * Asthma * Chronic obstructive pulmonary disease * Urinary tract obstruction * Cardiac conduction abnormalit...

Countries:United States
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