CompletedPhase 1

Effect on the Electrocardiographic QT Interval Corrected for Heart Rate (QTc) in Healthy Subjects

Randomized, Double-Blinded, Placebo-Controlled, Open Label Positive- Controlled, Four-Way Crossover Study of the Electrocardiographic Effects of BMS-708163 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

•Healthy volunteers

Primary endpoint

•Effect on the electrocardiographic QT interval corrected for heart rate (QTc)

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 IDCN156-020

NCT IDNCT00979316

Timeline

Milestones

Study start2009-09 (month precision)

Study first posted2009-09-18estimated

Primary completion2010-02actual (month precision)

Study completion2010-02actual (month precision)

Last update posted2011-01-07estimated

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 volunteersAccepted

Inclusion criteria

•Body Mass Index (BMI) of 18 to 32 kg/m², inclusive.

•Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 55

•Healthy subjects

Exclusion criteria

•History of cardiac arrhythmias or palpitations associated with presyncope or syncope, or history of unexplained syncope

•Sexually active fertile men not using effective birth control (double barrier) if their partners are WOCBP

•Women who are pregnant or breastfeeding

•History of allergy or intolerance to moxifloxacin or any member of the quinolone class of antimicrobial agents

•History of hypokalemia, history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age

•Any clinically significant ECG abnormality

•History of seizure disorders

•History of drowning survival

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.

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Effect on the electrocardiographic QT interval corrected for heart rate (QTc) in healthy subjects

Time frame:Serial triplicate ECGs at -60, -40 and -20 minutes prior to dosing: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 16 and 22.5 hours after dosing on Day 1 in each period

descriptive

Secondary/protocol endpoint/low confidence

To assess the effects of BMS-708163 on other ECG endpoints (heart rate [HR], QRS and PR intervals), and changes in waveform morphology

Time frame:At -60, -40 and -20 minutes prior to dosing; at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 16 and 22.5 hours after dosing on Day 1 in each period

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.