Status:
COMPLETED
A Study of Healthy Subjects to Assess the Effect of LY450139 on Amyloid Beta Peptide Production Rate and or Dose Response.
Lead Sponsor:
Eli Lilly and Company
Conditions:
Alzheimer Disease
Eligibility:
MALE
21-50 years
Phase:
PHASE1
Brief Summary
To test that LY450139, a gamma-secretase inhibitor, will reduce the rate of newly synthesize Amyloid Beta by determining the amount of newly synthesized 13C6 leucine-labeled Amyloid Beta in lumbar cer...
Eligibility Criteria
Inclusion
- Healthy volunteers: Men within the ages of 21 and 50
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00765115
Start Date
July 1 2006
End Date
September 1 2007
Last Update
October 2 2008
Active Locations (1)
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1
For additional information regarding investigtive sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
St Louis, Missouri, United States, 63130