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CompletedPhase 1

A Safety Study of LY2811376 Single Doses in Healthy Subjects

Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2811376 in Healthy Subjects

Asset

LY2811376

Listed sites

1

Recruiting sites

-

Enrollment

61

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 20-65

Primary endpoint

•Clinical Effects

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 ID12852
SecondaryI3J-MC-LACE
NCT IDNCT00838084

Timeline

Milestones

Study start2008-12 (month precision)
Study first posted2009-02-06estimated
Primary completion2009-06actual (month precision)
Study completion2009-06actual (month precision)
Last update posted2009-07-15estimated

Assets

Drug assets

LY2811376

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age20 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Healthy men and nonchild-bearing potential women
•20 years or older
•Body mass index between 18-32kg/m2

Exclusion criteria

•Taking over-the-counter or prescription medication with the exception of vitamins or minerals or stable doses of thyroid or estrogen hormone replacement.
•Smoke more than 10 cigarettes per day.
•Consume more than 5 cups of coffee per day.

Endpoints (7)

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

Amyloid biomarkers
2
Fluid / digital biomarkers
2
Safety / tolerability / PK
2
Other (unclassified)
1

Amyloid biomarkers

2 endpoints
Secondary/protocol endpoint

Amyloid beta 1-40 plasma concentrations

Time frame:Predose and up to Day 6 of each period

concentration, descriptive

Secondary/protocol endpoint

Amyloid beta 1-40 cerebrospinal fluid CSF concentrations (Part 2 only)

Time frame:Predose and up to 36 hours

concentration, descriptive

Fluid / digital biomarkers

2 endpoints
Secondary/protocol endpoint

Cerebrospinal fluid (CSF) concentration of LY2811376 (Cmax) (Part 2 only)

Time frame:Predose and up to 36 hours

concentration, descriptive

Secondary/protocol endpoint

Cerebrospinal fluid (CSF) concentration of LY2811376 (AUC) (Part 2 only)

Time frame:Predose and up to 36 hours

concentration, descriptive

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Plasma concentration of LY2811376 (Cmax)

Time frame:Predose and up to Day 6 of each period

concentration, descriptive

Secondary/protocol endpoint

Plasma concentration of LY2811376 (AUC)

Time frame:Predose and up to Day 6 of each period

concentration, descriptive

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Clinical Effects

Time frame:Predose and up to Day 6 of each period

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

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.