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A Safety Study of LY2811376 Single Doses in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00838084
First received: January 23, 2009
Last updated: July 14, 2009
Last verified: July 2009

January 23, 2009
July 14, 2009
December 2008
June 2009   (Final data collection date for primary outcome measure)
Clinical Effects [ Time Frame: Predose and up to Day 6 of each period ]
Same as current
Complete list of historical versions of study NCT00838084 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Safety Study of LY2811376 Single Doses in Healthy Subjects
Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2811376 in Healthy Subjects
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Alzheimer's Disease
  • Drug: LY2811376
    Oral capsules
  • Drug: Placebo
    Oral capsules
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
June 2009
June 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00838084
12852
I3J-MC-LACE
No
Not Provided
Not Provided
Not Provided
Chief Medical Officer, 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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
July 2009

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