Drug-Drug Interaction Study With Aricept® (Donepezil)

• ClinicalTrials.gov Identifier: NCT01042314
• Recruitment Status: Completed
• First Posted: January 5, 2010
• Last Update Posted: January 25, 2011
• Sponsor: Bristol-Myers Squibb
• Information provided by: Bristol-Myers Squibb

Tracking Information

• First Submitted Date: December 22, 2009
• First Posted Date: January 5, 2010
• Last Update Posted Date: January 25, 2011
• Study Start Date: January 2010
• Actual Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 4, 2010): 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 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: January 4, 2010): Aricept® alone and with BMS-708163: Safety and tolerability based on adverse events, ECG, vital signs and safety labs [ Time Frame: Days 7, 14, 21, 29 and study discharge ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Drug-Drug Interaction Study With Aricept® (Donepezil)
• Official Title: A Study of the Effect of Concomitant Administration of BMS-708163 on the Pharmacokinetics of Donepezil in Healthy Subjects
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label)
• Condition: Alzheimer Disease

Intervention

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

Study Arms

Experimental: Donepezil and BMS-708163

Interventions:

• Drug: Donepezil
• Drug: BMS-708163

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 4, 2010): 18
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 2010
• Actual Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)

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
• Inability to be venipunctured and/or tolerate venous access

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01042314
• Other Study ID Numbers: CN156-008
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Study Director, Bristol-Myers Squibb
• Original Responsible Party: Same as current
• Current Study Sponsor: Bristol-Myers Squibb
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: April 2010