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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

Tracking Information
First Submitted Date  ICMJE October 21, 2010
First Posted Date  ICMJE October 25, 2010
Results First Submitted Date  ICMJE May 9, 2019
Results First Posted Date  ICMJE July 19, 2019
Last Update Posted Date July 19, 2019
Study Start Date  ICMJE December 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2010)
Number of Participants With Clinically Significant Effects [ Time Frame: Predose up to Day 70 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Plasma Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY2886721 [ Time Frame: Predose (Day 14) up to Day 19 ]
  • 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.
  • 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.
  • Cerebrospinal Fluid (CSF) Concentration of LY2886721 [ Time Frame: 24 Hours post-dose (Day 15) ]
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2010)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety Study of LY2886721 Multiple Doses in Healthy Subjects
Official Title  ICMJE Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: LY2886721
    5 milligrams (mg) up to 35 mg, administered orally as capsules, daily for 14 days
  • Drug: Placebo
    Administered orally as capsules, daily for 14 days
Study Arms  ICMJE
  • Experimental: LY2886721
    Intervention: Drug: LY2886721
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2011)
42
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2010)
60
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01227252
Other Study ID Numbers  ICMJE 13734
I4O-MC-BACB ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date May 2019

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