Drug-Drug Interaction Study With Aricept® (Donepezil)

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042314
• Other study ID #: CN156-008
• Status: Completed
• Phase: Phase 1
• First received: December 22, 2009
• Last updated: January 24, 2011
• Start date: January 2010
• Est. completion date: April 2010

Study information

• Verified date: April 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Donepezil
Tablets, Oral, 5 mg, Once Daily, Days 1-28
• BMS-708163
Capsule, Oral, 125 mg, Once Daily, Days 15-28

Locations

Country	Name	City	State
United States	Parexel International - Baltimore Epcu	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form