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CompletedNCT00765115Updated Oct 2, 2008

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

A Phase 1 interventional study of LY450139 and placebo in Alzheimer Disease, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to male participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-10-02.

Sponsored by Eli Lilly and Company · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
21 Years to 50 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Alzheimer Disease

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03

In context

Alzheimer Disease

3,765 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.

This study's enrollment of 27 is below the median of 68 across 2,861 interventional studies indexed under Alzheimer Disease.

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Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.

Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy volunteers: Men within the ages of 21 and 50

Exclusion criteria

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
27 participants (actual)

Study arms

  • 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

Interventions

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

07

Study locations

1 site
  • 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 63130, United States
08

References and documents

Publications

  • 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. PubMed 26948580 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00765115
Lead sponsor
Eli Lilly and Company
First posted
Oct 2, 2008
Start date
Jul 2006
Primary completion
Sep 2007
Completion
Sep 2007
Last update
Oct 2, 2008

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Semagacestat

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