Drug-Drug Interaction Study With Aricept® (Donepezil)

Phase 1

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: Donepezil; Drug: BMS-708163

• 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

Study Timeline

• Study First Submitted: 2009-12-22
• Study Start: 2010-01
• Study First Submitted QC: 2010-01-04
• Study First Posted: 2010-01-05
• Status Verified: 2010-04
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25

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