Back to resultsA Study of LY2951742 in Healthy Japanese and Caucasian Participants
Primary Purpose
Migraine Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY2951742
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Migraine Disorders
Eligibility Criteria
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.
Sites / Locations
- 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.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
5 mg LY2951742 Single Dose
50 mg LY2951742 Single Dose
120 mg LY2951742 Single Dose
300 mg LY2951742 Single Dose
300 mg LY2951742 Multiple Dose
Placebo Single Dose
Placebo Multiple Dose
Arm Description
5 mg LY2951742 given subcutaneously once
50 mg LY2951742 given subcutaneously once
120 mg LY2951742 given subcutaneously once
300 mg LY2951742 given subcutaneously once
300 mg LY2951742 given subcutaneously once every 4 weeks (Q4W)
Placebo given subcutaneously once
Placebo given subcutaneously once every 4 weeks (Q4W)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02104765
Brief Title
A Study of LY2951742 in Healthy Japanese and Caucasian Participants
Official Title
A Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2951742 Administered Subcutaneously to Japanese and Caucasian Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
5 mg LY2951742 Single Dose
Arm Type
Experimental
Arm Description
5 mg LY2951742 given subcutaneously once
Arm Title
50 mg LY2951742 Single Dose
Arm Type
Experimental
Arm Description
50 mg LY2951742 given subcutaneously once
Arm Title
120 mg LY2951742 Single Dose
Arm Type
Experimental
Arm Description
120 mg LY2951742 given subcutaneously once
Arm Title
300 mg LY2951742 Single Dose
Arm Type
Experimental
Arm Description
300 mg LY2951742 given subcutaneously once
Arm Title
300 mg LY2951742 Multiple Dose
Arm Type
Experimental
Arm Description
300 mg LY2951742 given subcutaneously once every 4 weeks (Q4W)
Arm Title
Placebo Single Dose
Arm Type
Placebo Comparator
Arm Description
Placebo given subcutaneously once
Arm Title
Placebo Multiple Dose
Arm Type
Placebo Comparator
Arm Description
Placebo given subcutaneously once every 4 weeks (Q4W)
Intervention Type
Drug
Intervention Name(s)
LY2951742
Intervention Description
Administered subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered subcutaneously.
Primary Outcome Measure Information:
Title
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Description
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 Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2951742
Description
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
Title
Pharmacokinetics (PK): Area Under the Concentration Curve, Zero to Infinity ( AUC[0-∞])
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31482569
Citation
Kielbasa W, Quinlan T. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine. J Clin Pharmacol. 2020 Feb;60(2):229-239. doi: 10.1002/jcph.1511. Epub 2019 Sep 4.
Results Reference
derived
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A Study of LY2951742 in Healthy Japanese and Caucasian Participants
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