A Study of LY2951742 in Healthy Japanese and Caucasian Participants

Phase 1

Completed

• Conditions: Migraine Disorders
• Interventions: Drug: LY2951742; Drug: Placebo

• Registration Number: NCT02104765
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-02
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-04
• Study Start: 2014-06
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Results First Submitted: 2018-10-08
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-13
• Last Update Submitted: 2019-03-13
• Results First Posted: 2019-06-14
• Last Update Posted: 2019-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5 mg LY2951742 Single Dose	LY2951742	5 mg LY2951742 given subcutaneously once
50 mg LY2951742 Single Dose	LY2951742	50 mg LY2951742 given subcutaneously once
120 mg LY2951742 Single Dose	LY2951742	120 mg LY2951742 given subcutaneously once
300 mg LY2951742 Single Dose	LY2951742	300 mg LY2951742 given subcutaneously once
300 mg LY2951742 Multiple Dose	LY2951742	300 mg LY2951742 given subcutaneously once every 4 weeks (Q4W)
Placebo Single Dose	Placebo	Placebo given subcutaneously once
Placebo Multiple Dose	Placebo	Placebo given subcutaneously once every 4 weeks (Q4W)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2951742	Day 1: Predose, 8 hr and 24 hour postdose	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.
Pharmacokinetics (PK): Area Under the Concentration Curve, Zero to Infinity ( AUC[0-∞])	Day 1: Predose, 8 hr and 24 hour postdose	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.

Trial Locations

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