CompletedPhase 1

Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-708163

Randomized, Placebo-controlled, Double-blind, Single- and Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-708163 in Healthy Young Male and Elderly Male and Female Chinese 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

Primary endpoint

•Safety assessments will be

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 IDCN156-029

NCT IDNCT01079819

Timeline

Milestones

Study first posted2010-03-03estimated

Study start2010-04 (month precision)

Primary completion2010-12actual (month precision)

Study completion2010-12actual (month precision)

Last update posted2011-02-07estimated

Assets

Drug assets

Avagacestat

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Healthy male subjects 18-45 yrs old and 65 yrs or older inclusive and postmenopausal female 65 yrs or older

Exclusion criteria

•Women of childbearing potential

•Gastrointestinal disorders

•Bleeding disorders

•Peptic ulcer disease

•Abnormal ECG

•Abnormal Clinical laboratory tests

•Abnormal Thyroid

•Congestive heart failure

•Cholecystectomy

•Asthma

•Hypertension

•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

Safety assessments will be based on adverse event reports and the results of vital sign measurements, ECGs, physical exams and clinical laboratory tests. Adverse events will be tabulated and reviewed for potential significance and clinical importance

Time frame:Study Day 1 through study completion + 30 days

event count, event

Secondary/protocol endpoint

Single-dose pharmacokinetic parameters (Cmax, Tmax, AUC(0-T), AUC(INF), T-HALF and multiple-dose pk parameters (Cmax, Tmax, Cmin, AUC(TAU), T-HALF, and accumulation index will be derived from plasma concentration versus time data

Time frame:Study Days 1-8 Period 1 and Days 1, 2, 5, 7, 9, 11, and 13-21 Period 2

concentration, descriptive

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.