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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00765115
First received: September 30, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Alzheimer Disease
Drug: LY450139
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Assessment of LY450139-Mediated Inhibition of Amyloid Beta Formation Determined by 13C6-Leucine In Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To test hypothesis that LY450139, a gamma-secretase inhibitor, will reduce the rate of synthesis of 13C6-leucine-labeled Aβ (newly synthesized) in lumbar cerebrospinal fluid (CSF). [ Time Frame: 0-36 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 0-36 hours post dose ] [ Designated as safety issue: No ]
  • To study and evaluate other biomarkers, such as sAPPB and sAPPA that may enable drug effectiveness to be predicted. [ Time Frame: 0-36 hours post dose ] [ Designated as safety issue: No ]
  • To measure concentrations of Amyloid Beta(1-40), Amyloid Beta(1-42), and leucine in CSF by mass spectrometry. [ Time Frame: 0-36 hours post dose ] [ Designated as safety issue: No ]
  • To explore the relationship between Amyloid Beta plasma decrease and Amyloid Beta synthesis rate as determined by CSF measurements. [ Time Frame: 0-36 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: July 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
100 mg LY 450139 oral
Drug: LY450139
Experimental: 2
140 mg LY450139 oral
Drug: LY450139
Experimental: 3
280 mg LY450139 oral
Drug: LY450139
Experimental: 4
Placebo
Drug: placebo

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765115

Locations
United States, Missouri
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Chief Medical Office, Eli Lilly
ClinicalTrials.gov Identifier: NCT00765115     History of Changes
Other Study ID Numbers: 9384, H6L-MC-LFAM
Study First Received: September 30, 2008
Last Updated: September 30, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014