Trial record 2 of 5 for:    LY2951742

A Study of LY2951742 in Healthy Japanese and Caucasian Participants

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02104765
First received: April 2, 2014
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Migraine Disorders
Drug: LY2951742
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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 [ Time Frame: Screening through Day 197 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maximum Concentration of LY2951742 [ Time Frame: Predose on Day 1 through Day 197 ] [ Designated as safety issue: No ]
  • Area Under the Concentration Curve of LY2951742 [ Time Frame: Predose on Day 1 through Day 197 ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: June 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2951742 Single Dose 1
Dose 1 of LY2951742 given subcutaneously once
Drug: LY2951742
Administered subcutaneously.
Experimental: LY2951742 Single Dose 2
Dose 2 of LY2951742 given subcutaneously once
Drug: LY2951742
Administered subcutaneously.
Experimental: LY2951742 Single Dose 3
Dose 3 of LY2951742 given subcutaneously once
Drug: LY2951742
Administered subcutaneously.
Experimental: LY2951742 Single Dose 4
Dose 4 of LY2951742 given subcutaneously once
Drug: LY2951742
Administered subcutaneously.
Experimental: LY2951742 Multiple Dose
LY2951742 given subcutaneously once every 4 weeks for 8 weeks
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 for 8 weeks
Drug: Placebo
Administered subcutaneously.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02104765

Locations
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
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02104765     History of Changes
Other Study ID Numbers: 15435, I5Q-MC-CGAE
Study First Received: April 2, 2014
Last Updated: October 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases

ClinicalTrials.gov processed this record on October 21, 2014