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

Lilly

Status and phase

Completed

Phase 1

Conditions

Alzheimer Disease

Treatments

Drug: LY450139

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00765115

9384

H6L-MC-LFAM

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

Male

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

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