Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects

Eli Lilly and Company1 site in 1 country42 target enrollmentDecember 2010

ConditionsAlzheimer's Disease

InterventionsLY2886721 Placebo

DrugsLY2886721 Placebo

Overview

Phase: Phase 1
Intervention: LY2886721
Conditions: Alzheimer's Disease
Sponsor: Eli Lilly and Company
Enrollment: 42
Locations: 1
Primary Endpoint: Number of Participants With Clinically Significant Effects
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

April 2011

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

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

Arms & Interventions

LY2886721

Intervention: LY2886721

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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 Outcomes

Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721(Predose (Day 14) to 24 Hours post-dose (Day 15))
Plasma Amyloid Beta (Aβ) 1-40 Concentration(Predose (Day 14) up to Day 19)
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))
Plasma Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY2886721(Predose (Day 14) up to Day 19)