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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765115
• Other study ID #: 9384
• Secondary ID: H6L-MC-LFAM
• Status: Completed
• Phase: Phase 1
• First received: September 30, 2008
• Last updated: September 30, 2008
• Start date: July 2006
• Est. completion date: September 2007

Study information

• Verified date: September 2008
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• LY450139

• placebo

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To test hypothesis that LY450139, a gamma-secretase inhibitor, will reduce the rate of synthesis of 13C6-leucine-labeled Aß (newly synthesized) in lumbar cerebrospinal fluid (CSF).		0-36 hours post dose	No
Secondary	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.		0-36 hours post dose	No
Secondary	To study and evaluate other biomarkers, such as sAPPB and sAPPA that may enable drug effectiveness to be predicted.		0-36 hours post dose	No
Secondary	To measure concentrations of Amyloid Beta(1-40), Amyloid Beta(1-42), and leucine in CSF by mass spectrometry.		0-36 hours post dose	No
Secondary	To explore the relationship between Amyloid Beta plasma decrease and Amyloid Beta synthesis rate as determined by CSF measurements.		0-36 hours post dose	No