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OpenTrials
Completed

NCT Number: NCT00765115

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

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.

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Key information

Age range

21 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY450139

Drug

Placebo

Drug

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Assessment of LY450139-Mediated Inhibition of Amyloid Beta Formation Determined by 13C6-Leucine In Healthy Subjects

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 2, 2008
Registry last updated
Oct 2, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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