Back to resultsA Safety Study of LY2886721 Multiple Doses in Healthy Subjects
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY2886721
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Alzheimer's Disease
Eligibility 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
Sites / Locations
- 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.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LY2886721
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Clinically Significant Effects
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
Plasma Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY2886721
Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721
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
The minimum concentration (Cnadir) is being reported for this outcome measure.
Cerebrospinal Fluid (CSF) Concentration of LY2886721
Change From Baseline to Day 15 Endpoint in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ) 1-40 Concentration
The Least Squares means were adjusted for baseline concentration.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01227252
Brief Title
A Safety Study of LY2886721 Multiple Doses in Healthy Subjects
Official Title
Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY2886721
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
LY2886721
Intervention Description
5 milligrams (mg) up to 35 mg, administered orally as capsules, daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally as capsules, daily for 14 days
Primary Outcome Measure Information:
Title
Number of Participants With Clinically Significant Effects
Description
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.
Time Frame
Predose up to Day 70
Secondary Outcome Measure Information:
Title
Plasma Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY2886721
Time Frame
Predose (Day 14) up to Day 19
Title
Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721
Description
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.
Time Frame
Predose (Day 14) to 24 Hours post-dose (Day 15)
Title
Plasma Amyloid Beta (Aβ) 1-40 Concentration
Description
The minimum concentration (Cnadir) is being reported for this outcome measure.
Time Frame
Predose (Day 14) up to Day 19
Title
Cerebrospinal Fluid (CSF) Concentration of LY2886721
Time Frame
24 Hours post-dose (Day 15)
Title
Change From Baseline to Day 15 Endpoint in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ) 1-40 Concentration
Description
The Least Squares means were adjusted for baseline concentration.
Time Frame
Predose (Day 14), 24 Hours post-dose (Day 15)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
12. IPD Sharing Statement
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A Safety Study of LY2886721 Multiple Doses in Healthy Subjects
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