A Study of LY2951742 in Healthy Japanese and Caucasian Participants

Eli Lilly and Company45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Migraine Disorders

Interventions

LY2951742DRUG

Administered subcutaneously.

PlaceboDRUG

Administered subcutaneously.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

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.

Cypress, California, United States

Outcomes

Primary Outcomes

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

Time frame: Baseline through Day 197

Secondary Outcomes

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.

Time frame: 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.

Time frame: Day 1: Predose, 8 hr and 24 hour postdose

Data from ClinicalTrials.gov

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