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A Safety Study of LY2811376 Single Doses in Healthy Subjects

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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

Tracking Information
First Submitted Date  ICMJE January 23, 2009
First Posted Date  ICMJE February 6, 2009
Last Update Posted Date July 15, 2009
Study Start Date  ICMJE December 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2009)
Clinical Effects [ Time Frame: Predose and up to Day 6 of each period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00838084 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2009)
  • Plasma concentration of LY2811376 (Cmax) [ Time Frame: Predose and up to Day 6 of each period ]
  • Plasma concentration of LY2811376 (AUC) [ Time Frame: Predose and up to Day 6 of each period ]
  • Amyloid beta 1-40 plasma concentrations [ Time Frame: Predose and up to Day 6 of each period ]
  • Cerebrospinal fluid (CSF) concentration of LY2811376 (Cmax) (Part 2 only) [ Time Frame: Predose and up to 36 hours ]
  • Cerebrospinal fluid (CSF) concentration of LY2811376 (AUC) (Part 2 only) [ Time Frame: Predose and up to 36 hours ]
  • Amyloid beta 1-40 cerebrospinal fluid CSF concentrations (Part 2 only) [ Time Frame: Predose and up to 36 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety Study of LY2811376 Single Doses in Healthy Subjects
Official Title  ICMJE Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2811376 in Healthy Subjects
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: LY2811376
    Oral capsules
  • Drug: Placebo
    Oral capsules
Study Arms  ICMJE
  • 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.
    Intervention: Drug: LY2811376
  • Placebo Comparator: Placebo Part 1
    once a day or twice a day for 1 day in up to 3 periods.
    Intervention: Drug: Placebo
  • Experimental: LY2811376 - Part 2 low dose
    Single dose of LY2811376, dose determined by part 1
    Intervention: Drug: LY2811376
  • Experimental: LY2811376 - Part 2 high dose
    Single dose of LY2811376, dose determined by part 1
    Intervention: Drug: LY2811376
  • Placebo Comparator: Placebo Part 2
    single dose
    Intervention: Drug: Placebo
Publications * Portelius E, Dean RA, Andreasson U, Mattsson N, Westerlund A, Olsson M, Demattos RB, Racke MM, Zetterberg H, May PC, Blennow K. β-site amyloid precursor protein-cleaving enzyme 1(BACE1) inhibitor treatment induces Aβ5-X peptides through alternative amyloid precursor protein cleavage. Alzheimers Res Ther. 2014 Nov 17;6(5-8):75. doi: 10.1186/s13195-014-0075-0. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2009)
61
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2009)
75
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00838084
Other Study ID Numbers  ICMJE 12852
I3J-MC-LACE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Medical Officer, Eli Lilly
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date July 2009

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