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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: LY2886721 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects
Study Start Date : December 2010
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: LY2886721 Drug: LY2886721
5 mg up to 35 mg, administered orally as capsules, daily for 14 days
Placebo Comparator: Placebo Drug: Placebo
Administered orally as capsules, daily for 14 days

Primary Outcome Measures :
  1. Number of participants with Clinically Significant Effects [ Time Frame: Predose up to Day 70 ]

Secondary Outcome Measures :
  1. Plasma maximum observed drug concentration at steady state (Cmax,ss) of LY2886721 [ Time Frame: Predose up to Day 19 ]
  2. Plasma area under the concentration versus time curve (AUC) of LY2886721 [ Time Frame: Predose up to Day 19 ]
  3. Plasma Abeta 1-40 concentration [ Time Frame: Predose up to Day 23 ]
  4. Cerebrospinal fluid (CSF) concentration of LY2886721 [ Time Frame: Day 15 ]
  5. Change from baseline to Day 15 endpoint in cerebrospinal fluid (CSF) Abeta 1-40 concentration [ Time Frame: Predose and Day 15 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT01227252

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, 91206
Sponsors and Collaborators
Eli Lilly and Company
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

Responsible Party: Chief Medical Officer, Eli Lilly Identifier: NCT01227252     History of Changes
Other Study ID Numbers: 13734
I4O-MC-BACB ( Other Identifier: Eli Lilly and Company )
First Posted: October 25, 2010    Key Record Dates
Last Update Posted: May 10, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders