Drug-Drug Interaction Study With Aricept® (Donepezil)

January 24, 2011 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21225
        • Parexel International - Baltimore Epcu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Donepezil and BMS-708163
Drug: Donepezil
Tablets, Oral, 5 mg, Once Daily, Days 1-28
Other Names:
  • Aricept®
Drug: BMS-708163
Capsule, Oral, 125 mg, Once Daily, Days 15-28

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Days 14 and 28

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Days 7, 14, 21, 29 and study discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

December 22, 2009

First Submitted That Met QC Criteria

January 4, 2010

First Posted (Estimate)

January 5, 2010

Study Record Updates

Last Update Posted (Estimate)

January 25, 2011

Last Update Submitted That Met QC Criteria

January 24, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN156-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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