A Study of the Effect of Concomitant Administration of BMS-708163 on the Pharmacokinetics of Donepezil in Healthy Subjects

Bristol-Myers Squibb1 site in 1 country18 target enrollmentJanuary 2010

ConditionsAlzheimer Disease

InterventionsDonepezil BMS-708163

DrugsDonepezil BMS-708163

Overview

Phase: Phase 1
Intervention: Donepezil
Conditions: Alzheimer Disease
Sponsor: Bristol-Myers Squibb
Enrollment: 18
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

April 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Eligibility Criteria

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

Arms & Interventions

Donepezil and BMS-708163

Intervention: Donepezil

Donepezil and BMS-708163

Intervention: BMS-708163

Outcomes

Primary Outcomes

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

Time Frame: Days 14 and 28

Secondary Outcomes

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)