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:
Eli Lilly and Company
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
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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:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
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 May 19, 2013