Drug-Drug Interaction Study With Aricept® (Donepezil)
- Registration Number
- NCT01042314
- Lead Sponsor
- Bristol-Myers Squibb
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Donepezil and BMS-708163 Donepezil - Donepezil and BMS-708163 BMS-708163 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Parexel International - Baltimore Epcu
🇺🇸Baltimore, Maryland, United States