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

Completed · Phase 1 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

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 cerebrospinal fluid from LY450139 treated subjects compared with placebo treated subjects.

Key facts

Study ID

NCT00765115

Run by

Eli Lilly and Company

People needed

27

Starts

2006-07-01

Expected to finish

2007-09-01

Last updated by the study team

2008-10-02

Who can join

Age: 21 and older, up to 50. Sex: male. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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