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A Study of LY2951742 in Healthy Japanese and Caucasian Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104765
Recruitment Status : Completed
First Posted : April 4, 2014
Results First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Migraine Disorders Drug: LY2951742 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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 Start Date : June 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 5 mg LY2951742 Single Dose
5 mg LY2951742 given subcutaneously once
Drug: LY2951742
Administered subcutaneously.

Experimental: 50 mg LY2951742 Single Dose
50 mg LY2951742 given subcutaneously once
Drug: LY2951742
Administered subcutaneously.

Experimental: 120 mg LY2951742 Single Dose
120 mg LY2951742 given subcutaneously once
Drug: LY2951742
Administered subcutaneously.

Experimental: 300 mg LY2951742 Single Dose
300 mg LY2951742 given subcutaneously once
Drug: LY2951742
Administered subcutaneously.

Experimental: 300 mg LY2951742 Multiple Dose
300 mg LY2951742 given subcutaneously once every 4 weeks (Q4W)
Drug: LY2951742
Administered subcutaneously.

Placebo Comparator: Placebo Single Dose
Placebo given subcutaneously once
Drug: Placebo
Administered subcutaneously.

Placebo Comparator: Placebo Multiple Dose
Placebo given subcutaneously once every 4 weeks (Q4W)
Drug: Placebo
Administered subcutaneously.




Primary Outcome Measures :
  1. Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: 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 :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2951742 [ Time Frame: 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.

  2. Pharmacokinetics (PK): Area Under the Concentration Curve, Zero to Infinity ( AUC[0-∞]) [ Time Frame: 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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104765


Locations
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United States, California
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, 90630
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02104765     History of Changes
Other Study ID Numbers: 15435
I5Q-MC-CGAE ( Other Identifier: Eli Lilly and Company )
First Posted: April 4, 2014    Key Record Dates
Results First Posted: June 14, 2019
Last Update Posted: June 14, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases