CompletedPhase 1

Multiple Dose Japanese Bridging Study

Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-708163 125 mg in Healthy Japanese and Non-Japanese Subjects

Lead sponsor

Bristol-Myers Squibb

Asset

Avagacestat

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age 20-45•Male

Primary endpoint

•BMS-708163 or placebo in Japanese and non-Japanese

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 IDCN156-038

NCT IDNCT01057030

Timeline

Milestones

Study first posted2010-01-27estimated

Study start2010-03 (month precision)

Primary completion2010-06actual (month precision)

Study completion2010-06actual (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 age20 Years

Maximum age45 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Healthy Japanese and non-Japanese subjects

•Japanese subjects must be first generation Japanese and must demonstrate both maternal and paternal Japanese ancestry

•Non-Japanese subjects must not be of Japanese or Asian descent, ie, neither parent nor grandparent was born in Japan or in any Asian country

•BMI of 19 to 25 kg/m², for Japanese and non-Japanese subjects

•Men ages 20 to 45 years

Exclusion criteria

•Serum creatinine values above the normal range

•Urine protein or blood levels above the normal range

•Liver function tests above the normal range

•TSH, free T3, or free T4 outside the normal range

•Amylase or lipase levels above the normal range

•Positive Fecal Immunochemical Test (FIT™)

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

BMS-708163 or placebo in Japanese and non-Japanese: Safety and tolerability (AE's, ECG, vital signs, safety labs)

Time frame:Every day for 28 days

descriptive

Secondary/protocol endpoint

BMS-708163 pharmacokinetic parameters (Cmax, Cmin, Ctrough, Tmax, AUC(TAU), AI, and CLT/F and T-HALF (only following Day 14 dose))

Time frame:Days 1, 7, and 14

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.