A Study of LY2951742 in Healthy Japanese and Caucasian Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Migraine Disorders

Treatments: Drug: LY2951742; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02104765

I5Q-MC-CGAE (Other Identifier)

15435

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 7 patient groups, including a placebo group

5 mg LY2951742 Single Dose

Experimental group

Description:

5 mg LY2951742 given subcutaneously once

Treatment:

Drug: LY2951742

50 mg LY2951742 Single Dose

Experimental group

Description:

50 mg LY2951742 given subcutaneously once

Treatment:

Drug: LY2951742

120 mg LY2951742 Single Dose

Experimental group

Description:

120 mg LY2951742 given subcutaneously once

Treatment:

Drug: LY2951742

300 mg LY2951742 Single Dose

Experimental group

Description:

300 mg LY2951742 given subcutaneously once

Treatment:

Drug: LY2951742

300 mg LY2951742 Multiple Dose

Experimental group

Description:

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

Treatment:

Drug: LY2951742

Placebo Single Dose

Placebo Comparator group

Description:

Placebo given subcutaneously once

Treatment:

Drug: Placebo

Placebo Multiple Dose

Placebo Comparator group

Description:

Placebo given subcutaneously once every 4 weeks (Q4W)

Treatment:

Drug: Placebo