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galantamine

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

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

galantamine · 1 trial · 1 indication

Phase 1 1
NCT01039194Drug-Drug Interaction to Study the Effect of BMS-708163 on Pharmacokinetics (PK) of Galantamine Extended Release (ER)Alzheimer Disease
COMPLETED18 Analytics
PHASE1COMPLETED
Drug-Drug Interaction to Study the Effect of BMS-708163 on Pharmacokinetics (PK) of Galantamine Extended Release (ER)
Alzheimer DiseaseUnlock trial analytics

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 to 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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Frequently asked questions about galantamine

What is galantamine used for in Alzheimer Disease?

Galantamine is a small molecule being studied for use in Alzheimer Disease. It is an investigational drug in clinical development, and it is not approved for this use. The drug has been evaluated in a Phase 1 clinical trial to assess its effects in patients with Alzheimer Disease.

Who makes galantamine?

Galantamine is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical research on this small molecule for the treatment of Alzheimer Disease. The drug is currently in Phase 1 of clinical development.

What phase is galantamine in?

Galantamine is in Phase 1 of clinical development. It is an investigational drug being studied for Alzheimer Disease. The drug is not approved and remains in clinical trials. One Phase 1 study has been completed, and no active trials are currently listed for this asset.

What clinical trials is galantamine in?

Galantamine has been studied in one clinical trial, NCT01039194, titled "Drug-Drug Interaction to Study the Effect of BMS-708163 on Pharmacokinetics (PK) of Galantamine Extended Release (ER)." This Phase 1 study was completed in the United States and enrolled 18 participants with Alzheimer Disease.

Is galantamine the same as BMS-708163?

No, galantamine is not the same as BMS-708163. In the clinical trial NCT01039194, galantamine extended release was studied as a substrate to evaluate the effect of BMS-708163 on its pharmacokinetics. The trial was designed to assess a potential drug-drug interaction between the two compounds.