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CompletedPhase 1

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

Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-708163 in Healthy Male Subjects and a Comparison to Elderly Male and Female Subjects

Lead sponsor

Bristol-Myers Squibb

Asset

Avagacestat

Listed sites

0

Recruiting sites

-

Enrollment

116

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥18

Primary endpoint

•Safety and tolerability of Single doses of BMS-708163 in the range of 0.3

Identifiers

Registered as

Org study IDCN156-001

NCT IDNCT01454115

Timeline

Milestones

Study start2007-06 (month precision)

Primary completion2009-03actual (month precision)

Study completion2009-03actual (month precision)

Study first posted2011-10-18estimated

Last update posted2011-11-21estimated

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersAccepted

Eligibility criteria

•Panels 1- 8 and Panels 14-15: healthy male subjects between the ages of 18 to 45

•Panels 9 and 10: healthy elderly males and females ages 60 and greater

•Panel 11: healthy males between the ages of 46-59

•Panel 12: males and/or females either healthy or with mild cognitive impairment (MCI) between the ages of 60 and 74

•Panel 13: males and/or females, healthy or with Alzheimer's disease (AD) or MCI that were 75 years of age or greater

•Acceptable medical history, physical examinations, vital signs, electrocardiograms, hemoccult stool tests, and clinical laboratory evaluations

Endpoints (10)

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.

Coverage by outcome category

Safety / tolerability / PK

6

Other (unclassified)

4

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Safety and tolerability of Single doses of BMS-708163 in the range of 0.3 to 800 mg in the healthy subjects

Time frame:Within 28 days of dosing

event count, event

Secondary/protocol endpoint

Maximum observed plasma concentration (Cmax) of BMS-708163

Time frame:Within 28 days of dosing

concentration, descriptive

Secondary/protocol endpoint

Time of maximum observed plasma concentration (Tmax) of BMS-708163

Time frame:Within 28 days of dosing

concentration, descriptive

Secondary/protocol endpoint

Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-708163

Time frame:Within 28 days of dosing

concentration, descriptive

Secondary/protocol endpoint

Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-708163

Time frame:Within 28 days of dosing

concentration, descriptive

Secondary/protocol endpoint

Plasma half-life (T-HALF) of BMS-708163

Time frame:Within 28 days of dosing

concentration, descriptive

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Effects of BMS-708163 on cortisol and QT interval corrected for heart rate

Time frame:Within 28 days of dosing

descriptive

Secondary/protocol endpoint/low confidence

Effect of BMS-708163 on thyroid stimulating hormone (TSH), free triiodothyronine (T3), free thyroxine (T4), and lymphocyte subsets

Time frame:Within 28 days of dosing

descriptive

Secondary/protocol endpoint/low confidence

Bioavailability of BMS-708163 from a capsule formulation relative to a solution formulation

Time frame:Within 28 days of dosing

descriptive

Secondary/protocol endpoint/low confidence

Effect of food on the PK of BMS-708163 administered as a capsule formulation

Time frame:Within 28 days of dosing

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Tong G, Wang JS, Sverdlov O, Huang SP, Slemmon R, Croop R, Castaneda L, Gu H, Wong O, Li H, Berman RM, Smith C, Albright CF, Dockens RC. Multicenter, randomized, double-blind, placebo-controlled, single-ascending dose study of the oral gamma-secretase inhibitor BMS-708163 (Avagacestat): tolerability profile, pharmacokinetic parameters, and pharmacodynamic markers. Clin Ther. 2012 Mar;34(3):654-67. doi: 10.1016/j.clinthera.2012.01.022. Epub 2012 Feb 28.
PMID22381714via DERIVED

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.