Alzheimer Disease
Conditions
Brief summary
The purpose of this study is to find out if the plasma concentration of donepezil is changed when BMS-708163 is administered at the same time
Interventions
DRUGDonepezil
Tablets, Oral, 5 mg, Once Daily, Days 1-28
DRUGBMS-708163
Capsule, Oral, 125 mg, Once Daily, Days 15-28
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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 asthma * History of Chronic Obstructive Pulmonary Disease * History of cardiac conduction abnormalities, including but not limited to sick sinus syndrome and those with unexplained syncopal episodes * Inability to tolerate oral medication * Inability to be venipunctured and/or tolerate venous access
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed