A Study of LY2951742 in Healthy Japanese and Caucasian Participants

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the safety of the study drug known as LY2951742 in healthy Japanese and Caucasians. The study will also investigate how the body processes the drug and how the drug affects the body. The study is expected to last about 5 to 7 months, depending on the arm.

Official Title
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A Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2951742 Administered Subcutaneously to Japanese and Caucasian Healthy Subjects

Conditions
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Migraine Disorders

Intervention / Treatment
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* Drug: LY2951742
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants are either Caucasian or first generation Japanese. Participants' body mass index (BMI) is between 18.0 and 35.0 kilogram per meter square (kg/ m^2). Exclusion Criteria: Participants are heavy caffeine drinkers defined by regular intake of more than 5 cups of coffee (or equivalent in xanthine containing beverages) per day, and/or are unable or unwilling to abide by caffeine restrictions as specified in the protocol. Participants are smoking within the previous 6 months. Participants have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing or have received a vaccination within 1 month. Participants have known allergies to LY2951742, related compounds or any components of the formulation, or history of significant atopy. Participants are allergies to either humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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: 5 mg LY2951742 Single Dose<br>5 mg LY2951742 given subcutaneously once | Drug: LY2951742<br>* Administered subcutaneously.<br>|
| Experimental: 50 mg LY2951742 Single Dose<br>50 mg LY2951742 given subcutaneously once | Drug: LY2951742<br>* Administered subcutaneously.<br>|
| Experimental: 120 mg LY2951742 Single Dose<br>120 mg LY2951742 given subcutaneously once | Drug: LY2951742<br>* Administered subcutaneously.<br>|
| Experimental: 300 mg LY2951742 Single Dose<br>300 mg LY2951742 given subcutaneously once | Drug: LY2951742<br>* Administered subcutaneously.<br>|
| Experimental: 300 mg LY2951742 Multiple Dose<br>300 mg LY2951742 given subcutaneously once every 4 weeks (Q4W) | Drug: LY2951742<br>* Administered subcutaneously.<br>|
| Placebo Comparator: Placebo Single Dose<br>Placebo given subcutaneously once | Drug: Placebo<br>* Administered subcutaneously.<br>|
| Placebo Comparator: Placebo Multiple Dose<br>Placebo given subcutaneously once every 4 weeks (Q4W) | Drug: Placebo<br>* Administered subcutaneously.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section | Baseline through Day 197 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2951742 | Cmax was evaluated to delineate dose proportionality for the dose cohorts using a power model for geometric means and coefficient of variation. Statistical analysis was not prespecified. | Day 1: Predose, 8 hr and 24 hour postdose | 
| Pharmacokinetics (PK): Area Under the Concentration Curve, Zero to Infinity ( AUC[0-∞]) | AUC was evaluated to delineate dose proportionality for the dose cohorts using a power model for geometric means and coefficient of variation. Statistical analysis was not prespecified. | Day 1: Predose, 8 hr and 24 hour postdose |