CompletedPhase 1

Drug-Drug Interaction Study With Aricept® (Donepezil)

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

Lead sponsor

Bristol-Myers Squibb

Asset

Avagacestat

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 18-55

Primary endpoint

•Aricept® alone and with BMS-708163

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCN156-008

NCT IDNCT01042314

Timeline

Milestones

Study start2010-01 (month precision)

Study first posted2010-01-05estimated

Primary completion2010-04actual (month precision)

Study completion2010-04actual (month precision)

Last update posted2011-01-25estimated

Assets

Drug assets

Avagacestat

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

2 endpoints

Primary/protocol 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

Time frame:Days 14 and 28

concentration, descriptive

Secondary/protocol endpoint

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

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.