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CompletedPhase 1

A Study of Healthy Subjects to Assess the Effect of LY450139 on Amyloid Beta Peptide Production Rate and or Dose Response.

Assessment of LY450139-Mediated Inhibition of Amyloid Beta Formation Determined by 13C6-Leucine In Healthy Subjects

Lead sponsor

Eli Lilly and Company

Asset

Semagacestat

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Healthy volunteers

Primary endpoint

•To test hypothesis that LY450139, a gamma-secretase inhibitor

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 ID9384

SecondaryH6L-MC-LFAM

NCT IDNCT00765115

Timeline

Milestones

Study start2006-07 (month precision)

Primary completion2007-09actual (month precision)

Study completion2007-09actual (month precision)

Study first posted2008-10-02estimated

Last update posted2008-10-02estimated

Assets

Drug assets

Semagacestat

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age21 Years

Maximum age50 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Healthy volunteers: Men within the ages of 21 and 50

Exclusion criteria

•Have serious or unstable medical conditions

•Have a history of serious infections affecting the brain or head trauma resulting in protracted loss of consciousness within the last 5 years or multiple episodes of head trauma

•Have a history of primary or recurrent malignant disease

•Have a recent laboratory result indicating a clinically significant laboratory abnormality as determined by the investigator

•Have a history of chronic alcohol or drug abuse within the past 5 years

•Have a known history of Human immunodeficiency virus (HIV), afebrile seizures, or clinically significant multiple drug allergies

•Are judged clinically by the investigator to be at serious risk for suicide

•Have electrocardiogram abnormalities obtained at visit 1 that in the opinion of the investigator are clinically significant

•Use of prescription or over the counter medications that cannot safely be discontinued within 14 days prior to visit 2

•Have criteria that would preclude a LP such as allergy to all local anesthetics; have a local infection at the site of the LP or have any medical condition requiring treatment with warfarin or heparin.

•Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

•Are investigator site personnel directly affiliated with this study and or immediate families.

•Are Lilly employees

Endpoints (5)

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

Fluid / digital biomarkers

Other (unclassified)

Amyloid biomarkers

3 endpoints

Secondary/protocol endpoint

To test the hypothesis that LY450139 has an effect on fractional clearance rate of Amyloid Beta assayed from CSF samples in LY450139-treated subjects compared to placebo-treated subjects.