A Study of LY2951742 in Healthy Japanese and Caucasian Participants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-01-31

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.

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Detailed Description

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Conditions

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Migraine Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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5 mg LY2951742 Single Dose

5 mg LY2951742 given subcutaneously once

Group Type EXPERIMENTAL

LY2951742

Intervention Type DRUG

Administered subcutaneously.

50 mg LY2951742 Single Dose

50 mg LY2951742 given subcutaneously once

Group Type EXPERIMENTAL

LY2951742

Intervention Type DRUG

Administered subcutaneously.

120 mg LY2951742 Single Dose

120 mg LY2951742 given subcutaneously once

Group Type EXPERIMENTAL

LY2951742

Intervention Type DRUG

Administered subcutaneously.

300 mg LY2951742 Single Dose

300 mg LY2951742 given subcutaneously once

Group Type EXPERIMENTAL

LY2951742

Intervention Type DRUG

Administered subcutaneously.

300 mg LY2951742 Multiple Dose

300 mg LY2951742 given subcutaneously once every 4 weeks (Q4W)

Group Type EXPERIMENTAL

LY2951742

Intervention Type DRUG

Administered subcutaneously.

Placebo Single Dose

Placebo given subcutaneously once

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered subcutaneously.

Placebo Multiple Dose

Placebo given subcutaneously once every 4 weeks (Q4W)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered subcutaneously.

Interventions

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LY2951742

Administered subcutaneously.

Intervention Type DRUG

Placebo

Administered subcutaneously.

Intervention Type DRUG

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes