A Study of LY2951742 in Healthy Japanese and Caucasian Participants
A Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2951742 Administered Subcutaneously to Japanese and Caucasian Healthy Subjects
2 other identifiers
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2014
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2014
CompletedFirst Posted
Study publicly available on registry
April 4, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedResults Posted
Study results publicly available
June 14, 2019
CompletedJune 14, 2019
March 1, 2019
7 months
April 2, 2014
October 8, 2018
March 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Baseline through Day 197
Secondary Outcomes (2)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2951742
Day 1: Predose, 8 hr and 24 hour postdose
Pharmacokinetics (PK): Area Under the Concentration Curve, Zero to Infinity ( AUC[0-∞])
Day 1: Predose, 8 hr and 24 hour postdose
Study Arms (7)
5 mg LY2951742 Single Dose
EXPERIMENTAL5 mg LY2951742 given subcutaneously once
50 mg LY2951742 Single Dose
EXPERIMENTAL50 mg LY2951742 given subcutaneously once
120 mg LY2951742 Single Dose
EXPERIMENTAL120 mg LY2951742 given subcutaneously once
300 mg LY2951742 Single Dose
EXPERIMENTAL300 mg LY2951742 given subcutaneously once
300 mg LY2951742 Multiple Dose
EXPERIMENTAL300 mg LY2951742 given subcutaneously once every 4 weeks (Q4W)
Placebo Single Dose
PLACEBO COMPARATORPlacebo given subcutaneously once
Placebo Multiple Dose
PLACEBO COMPARATORPlacebo given subcutaneously once every 4 weeks (Q4W)
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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, 90630, United States
Related Publications (1)
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.
PMID: 31482569DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2014
First Posted
April 4, 2014
Study Start
June 1, 2014
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
June 14, 2019
Results First Posted
June 14, 2019
Record last verified: 2019-03