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Completed

NCT Number: NCT01042314

Drug-Drug Interaction Study With Aricept® (Donepezil)

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

Completed

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International - Baltimore Epcu

Baltimore, Maryland, 21225, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Donepezil

Drug

Tablets, Oral, 5 mg, Once Daily, Days 1-28

Other names: Aricept®

BMS-708163

Drug

Capsule, Oral, 125 mg, Once Daily, Days 15-28

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 5, 2010
Registry last updated
Jan 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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