Skip to main content
Delfa

← Trials/Trial dossier/NCT00860275

CompletedPhase 1

Drug-Drug Interaction (DDI) w/Ketoconazole or Fluconazole

A Study of the Effect of Concomitant Administration of Ketoconazole or Fluconazole on the Pharmacokinetics of BMS-708163 in Healthy Subjects

Asset

Avagacestat

Listed sites

1

Recruiting sites

-

Enrollment

30

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 18-55

Primary endpoint

•PK profile of 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 IDCN156-019
NCT IDNCT00860275

Timeline

Milestones

Study first posted2009-03-12estimated
Study start2009-04 (month precision)
Primary completion2009-06actual (month precision)
Study completion2009-06actual (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 age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

Eligibility criteria

•Healthy male and postmenopausal female subjects 18-55 yrs old inclusive

Exclusion:

•Premenopausal women

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.

Coverage by outcome category

Safety / tolerability / PK
1
Other (unclassified)
1

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Safety and tolerability of BMS-708163 when administered alone and with either ketoconazole or fluconazole

Time frame:During the entire study period

descriptive

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

PK profile of BMS-708163

Time frame:Within 14 days after dose

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.