A Safety Study of LY2886721 Multiple Doses in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01227252
First received: October 21, 2010
Last updated: May 9, 2011
Last verified: May 2011

October 21, 2010
May 9, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01227252 on ClinicalTrials.gov Archive Site
  • Plasma maximum observed drug concentration at steady state (Cmax,ss) of LY2886721 [ Time Frame: Predose up to Day 19 ] [ Designated as safety issue: No ]
  • Plasma area under the concentration versus time curve (AUC) of LY2886721 [ Time Frame: Predose up to Day 19 ] [ Designated as safety issue: No ]
  • Plasma Abeta 1-40 concentration [ Time Frame: Predose up to Day 23 ] [ Designated as safety issue: No ]
  • Cerebrospinal fluid (CSF) concentration of LY2886721 [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Change from baseline to Day 15 endpoint in cerebrospinal fluid (CSF) Abeta 1-40 concentration [ Time Frame: Predose and Day 15 ] [ Designated as safety issue: No ]
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
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
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
Both
20 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01227252
13734, I4O-MC-BACB
No
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