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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.
 
ClinicalTrials.gov Identifier: NCT01227252
Recruitment Status : Completed
First Posted : October 25, 2010
Results First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
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

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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
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY2886721 Drug: LY2886721
5 milligrams (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 ]
    Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module. The number of participants with at least 1 adverse event in each treatment arm is reported for this outcome measure.


Secondary Outcome Measures :
  1. Plasma Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY2886721 [ Time Frame: Predose (Day 14) up to Day 19 ]
  2. Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721 [ Time Frame: Predose (Day 14) to 24 Hours post-dose (Day 15) ]
    Area under the concentration versus time curve during 1 dosing interval (1 dosing interval=24 hours) at steady state (AUCτ,ss) is being reported for this outcome measure.

  3. Plasma Amyloid Beta (Aβ) 1-40 Concentration [ Time Frame: Predose (Day 14) up to Day 19 ]
    The minimum concentration (Cnadir) is being reported for this outcome measure.

  4. Cerebrospinal Fluid (CSF) Concentration of LY2886721 [ Time Frame: 24 Hours post-dose (Day 15) ]
  5. Change From Baseline to Day 15 Endpoint in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ) 1-40 Concentration [ Time Frame: Predose (Day 14), 24 Hours post-dose (Day 15) ]
    The Least Squares means were adjusted for baseline concentration.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Healthy men and non-childbearing potential women
  • Body mass index between 18.0-32.0 kilograms per square meter (kg/m^2)
  • 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 (for example, 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 ClinicalTrials.gov identifier (NCT number): NCT01227252


Locations
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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
Investigators
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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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01227252    
Other Study ID Numbers: 13734
I4O-MC-BACB ( Other Identifier: Eli Lilly and Company )
First Posted: October 25, 2010    Key Record Dates
Results First Posted: July 19, 2019
Last Update Posted: July 19, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders