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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 23, 2014