A Study of LY2951742 in Healthy Japanese and Caucasian Participants

Migraine Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104765
• Other study ID #: 15435
• Secondary ID: I5Q-MC-CGAE
• Status: Completed
• Phase: Phase 1
• Start date: June 2014
• Est. completion date: January 2015

Study information

• Verified date: March 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• LY2951742
Administered subcutaneously.
• Placebo
Administered subcutaneously.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Day 1: Predose, 8 hr and 24 hour postdose
Secondary	Pharmacokinetics (PK): Area Under the Concentration Curve, Zero to Infinity ( AUC[0-8])	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.	Day 1: Predose, 8 hr and 24 hour postdose