Trial record 4 of 7 for:    LY2886721

A Safety Study of LY2886721 Multiple 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. Identifier: NCT01227252
Recruitment Status : Completed
First Posted : October 25, 2010
Last Update Posted : May 10, 2011
Information provided by:
Eli Lilly and Company

October 21, 2010
October 25, 2010
May 10, 2011
December 2010
April 2011   (Final data collection date for primary outcome measure)
Number of participants with Clinically Significant Effects [ Time Frame: Predose up to Day 70 ]
Same as current
Complete list of historical versions of study NCT01227252 on Archive Site
  • Plasma maximum observed drug concentration at steady state (Cmax,ss) of LY2886721 [ Time Frame: Predose up to Day 19 ]
  • Plasma area under the concentration versus time curve (AUC) of LY2886721 [ Time Frame: Predose up to Day 19 ]
  • Plasma Abeta 1-40 concentration [ Time Frame: Predose up to Day 23 ]
  • Cerebrospinal fluid (CSF) concentration of LY2886721 [ Time Frame: Day 15 ]
  • Change from baseline to Day 15 endpoint in cerebrospinal fluid (CSF) Abeta 1-40 concentration [ Time Frame: Predose and Day 15 ]
Same as current
Not Provided
Not Provided
A Safety Study of LY2886721 Multiple Doses in Healthy Subjects
Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects
This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2886721 multiple doses, how the body handles the drug, and the drug's effect on the body.
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Alzheimer's Disease
  • Drug: LY2886721
    5 mg up to 35 mg, administered orally as capsules, daily for 14 days
  • Drug: Placebo
    Administered orally as capsules, daily for 14 days
  • Experimental: LY2886721
    Intervention: Drug: LY2886721
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2011
April 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy men and non-childbearing potential women
  • Body mass index between 18.0-32.0 kg/m2
  • Are reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures and research unit policies

Exclusion Criteria:

  • Taking over-the-counter or prescription medication with the exception of vitamins or minerals
  • Smoke more than 10 cigarettes per day
  • Drink more than 5 cups of caffeine containing beverages (e.g., coffee, tea) per day
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
I4O-MC-BACB ( Other Identifier: Eli Lilly and Company )
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
May 2011

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