Drug-Drug Interaction Study With Aricept® (Donepezil)
A Study of the Effect of Concomitant Administration of BMS-708163 on the Pharmacokinetics of Donepezil in Healthy Subjects
1 other identifier
interventional
18
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 alzheimer-disease
Started Jan 2010
Shorter than P25 for phase_1 alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedFirst Posted
Study publicly available on registry
January 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJanuary 25, 2011
April 1, 2010
3 months
December 22, 2009
January 24, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (1)
Donepezil and BMS-708163
EXPERIMENTALInterventions
Tablets, Oral, 5 mg, Once Daily, Days 1-28
Eligibility Criteria
You may qualify if:
- Healthy men and postmenopausal women
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Parexel International - Baltimore Epcu
Baltimore, Maryland, 21225, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 22, 2009
First Posted
January 5, 2010
Study Start
January 1, 2010
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
January 25, 2011
Record last verified: 2010-04