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A Safety Study of LY2811376 Single Doses in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00838084
Recruitment Status : Completed
First Posted : February 6, 2009
Last Update Posted : July 15, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Study Description
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Brief Summary:
This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2811376 single doses, how the body handles the drug, and the drug's effect on the body.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: LY2811376 Drug: Placebo Phase 1

Detailed Description:
This is a Phase 1 study with 2 parts, both in healthy subjects. Part 1 is a subject- and investigator-blind, placebo-controlled, randomized, 3 period, crossover study. Part 1 will assess the safety and tolerability of LY2811376 single doses, how the body handles the drug, and the drug's effect on the body. Part 2 is a subject- and investigator-blind, placebo-controlled, randomized study to assess the safety and tolerability of a LY2811376 single dose, how the body handles the drug, and the drug's effect on the body including in cerebrospinal fluid.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2811376 in Healthy Subjects
Study Start Date : December 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LY2811376 Part 1
LY2811376 (5 mg up to 500 mg); once a day or twice a day for 1 day in up to 3 periods.
 Drug: LY2811376
Oral capsules
Placebo Comparator: Placebo Part 1
once a day or twice a day for 1 day in up to 3 periods.
 Drug: Placebo
Oral capsules
Experimental: LY2811376 - Part 2 low dose
Single dose of LY2811376, dose determined by part 1
 Drug: LY2811376
Oral capsules
Experimental: LY2811376 - Part 2 high dose
Single dose of LY2811376, dose determined by part 1
 Drug: LY2811376
Oral capsules
Placebo Comparator: Placebo Part 2
single dose
 Drug: Placebo
Oral capsules


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Effects [ Time Frame: Predose and up to Day 6 of each period ]

Secondary Outcome Measures :
  1. Plasma concentration of LY2811376 (Cmax) [ Time Frame: Predose and up to Day 6 of each period ]
  2. Plasma concentration of LY2811376 (AUC) [ Time Frame: Predose and up to Day 6 of each period ]
  3. Amyloid beta 1-40 plasma concentrations [ Time Frame: Predose and up to Day 6 of each period ]
  4. Cerebrospinal fluid (CSF) concentration of LY2811376 (Cmax) (Part 2 only) [ Time Frame: Predose and up to 36 hours ]
  5. Cerebrospinal fluid (CSF) concentration of LY2811376 (AUC) (Part 2 only) [ Time Frame: Predose and up to 36 hours ]
  6. Amyloid beta 1-40 cerebrospinal fluid CSF concentrations (Part 2 only) [ Time Frame: Predose and up to 36 hours ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men and nonchild-bearing potential women
  • 20 years or older
  • Body mass index between 18-32kg/m2

Exclusion Criteria:

  • Taking over-the-counter or prescription medication with the exception of vitamins or minerals or stable doses of thyroid or estrogen hormone replacement.
  • Smoke more than 10 cigarettes per day.
  • Consume more than 5 cups of coffee per day.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838084


Locations
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United States, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Glendale, California, United States
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00838084    
Other Study ID Numbers: 12852
I3J-MC-LACE
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: July 15, 2009
Last Verified: July 2009
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders