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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

September 30, 2008
September 30, 2008
July 2006
September 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of Healthy Subjects to Assess the Effect of LY450139 on Amyloid Beta Peptide Production Rate and or Dose Response.
Assessment of LY450139-Mediated Inhibition of Amyloid Beta Formation Determined by 13C6-Leucine In Healthy Subjects

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Alzheimer Disease
  • Drug: LY450139
  • Drug: placebo
  • Experimental: 1
    100 mg LY 450139 oral
    Intervention: Drug: LY450139
  • Experimental: 2
    140 mg LY450139 oral
    Intervention: Drug: LY450139
  • Experimental: 3
    280 mg LY450139 oral
    Intervention: Drug: LY450139
  • Experimental: 4
    Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Male
21 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00765115
9384, H6L-MC-LFAM
No
Chief Medical Office, Eli Lilly
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP