A Study of Healthy Subjects to Assess the Effect of LY450139 on Amyloid Beta Peptide Production Rate and or Dose Response.
NCT ID: NCT00765115
Last Updated: 2008-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2006-07-31
2007-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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1
100 mg LY 450139 oral
LY450139
2
140 mg LY450139 oral
LY450139
3
280 mg LY450139 oral
LY450139
4
Placebo
placebo
Interventions
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LY450139
placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
21 Years
50 Years
MALE
Yes
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Eli Lilly
Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Countries
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References
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Holtta M, Dean RA, Siemers E, Mawuenyega KG, Sigurdson W, May PC, Holtzman DM, Portelius E, Zetterberg H, Bateman RJ, Blennow K, Gobom J. A single dose of the gamma-secretase inhibitor semagacestat alters the cerebrospinal fluid peptidome in humans. Alzheimers Res Ther. 2016 Mar 7;8(1):11. doi: 10.1186/s13195-016-0178-x.
Other Identifiers
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H6L-MC-LFAM
Identifier Type: -
Identifier Source: secondary_id
9384
Identifier Type: -
Identifier Source: org_study_id