A Safety Study of LY2886721 Multiple Doses in Healthy Subjects

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: LY2886721; Drug: Placebo

• Registration Number: NCT01227252
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-21
• Study First Submitted QC: 2010-10-21
• Study First Posted: 2010-10-25
• Study Start: 2010-12
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2019-05
• Results First Submitted: 2019-05-09
• Results First Submitted QC: 2019-05-09
• Last Update Submitted: 2019-05-09
• Results First Posted: 2019-07-19
• Last Update Posted: 2019-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY2886721	LY2886721	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinically Significant Effects	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

Name	Time	Method
Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721	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	Predose (Day 14) up to Day 19	The minimum concentration (Cnadir) is being reported for this outcome measure.
Cerebrospinal Fluid (CSF) Concentration of LY2886721	24 Hours post-dose (Day 15)
Change From Baseline to Day 15 Endpoint in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ) 1-40 Concentration	Predose (Day 14), 24 Hours post-dose (Day 15)	The Least Squares means were adjusted for baseline concentration.
Plasma Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY2886721	Predose (Day 14) up to Day 19

Trial Locations

Locations (1)

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