A Safety Study of LY2886721 Multiple Doses in Healthy Subjects

Study Overview
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Brief Summary
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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.

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

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: LY2886721
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY2886721<br> | Drug: LY2886721<br>* 5 milligrams (mg) up to 35 mg, administered orally as capsules, daily for 14 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Administered orally as capsules, daily for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Predose up to Day 70 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY2886721 |  | Predose (Day 14) up to Day 19 | 
| 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. | Predose (Day 14) to 24 Hours post-dose (Day 15) | 
| Plasma Amyloid Beta (Aβ) 1-40 Concentration | The minimum concentration (Cnadir) is being reported for this outcome measure. | 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 | The Least Squares means were adjusted for baseline concentration. | Predose (Day 14), 24 Hours post-dose (Day 15) |