CompletedNCT02104765Updated Jun 14, 2019Results posted

A Study of LY2951742 in Healthy Japanese and Caucasian Participants

A Phase 1 interventional study of LY2951742 and Placebo in Migraine Disorders, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-14.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 45
Allocation: Randomized
Ages: 20 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Migraine Disorders

Browse trials for

Migraine Disorders 1,528

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 45 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 45 participants (actual)

Study arms

Experimental
5 mg LY2951742 Single Dose
5 mg LY2951742 given subcutaneously once
Drug: LY2951742
Experimental
50 mg LY2951742 Single Dose
50 mg LY2951742 given subcutaneously once
Drug: LY2951742
Experimental
120 mg LY2951742 Single Dose
120 mg LY2951742 given subcutaneously once
Drug: LY2951742
Experimental
300 mg LY2951742 Single Dose
300 mg LY2951742 given subcutaneously once
Drug: LY2951742
Experimental
300 mg LY2951742 Multiple Dose
300 mg LY2951742 given subcutaneously once every 4 weeks (Q4W)
Drug: LY2951742
Placebo comparator
Placebo Single Dose
Placebo given subcutaneously once
Drug: Placebo
Placebo comparator
Placebo Multiple Dose
Placebo given subcutaneously once every 4 weeks (Q4W)
Drug: Placebo

Interventions

DrugLY2951742
Administered subcutaneously.
DrugPlacebo
Administered subcutaneously.

What researchers measure

Primary outcomes

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
Time frame: Baseline through Day 197

Secondary outcomes

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.
Time frame: Day 1: Predose, 8 hr and 24 hour postdose
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.
Time frame: Day 1: Predose, 8 hr and 24 hour postdose

Results

Posted Jun 14, 2019

Participant flow

Participant flow — Overall Study
Milestone	Placebo (SD)	5 mg LY2951742 Single Dose (SD)	50 mg LY2951742 (SD)	120 mg LY2951742 (SD)	300 mg LY2951742 (SD)	Placebo Q4W	300 mg LY2951742 Q4W
Started	8	6	6	7	8	2	8
Received at least 1 dose of study drug	8	6	6	7	8	2	8
Completed	8	6	5	6	7	2	7
Not completed	0	0	1	1	1	0	1
Withdrew: Lost to follow-up	0	0	1	0	0	0	0
Withdrew: Withdrawal by subject	0	0	0	1	1	0	1

Outcome measures

PrimaryNumber 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

Time frame:: Baseline through Day 197
Reported as:: Count of participants · Participants

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Participants	Placebo (SD)	5 mg LY2951742 Single Dose (SD)	50 mg LY2951742 (SD)	120 mg LY2951742 (SD)	300 mg LY2951742 (SD)	Placebo Q4W	300 mg LY2951742 Q4W
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	0	0	0	0	0	0	0

SecondaryPharmacokinetics (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.

Time frame:: Day 1: Predose, 8 hr and 24 hour postdose
Reported as:: Geometric mean · nanogram/millliliter (ng/mL)

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2951742
nanogram/millliliter (ng/mL)	5 mg LY2951742 (SD)	50 mg LY2951742 (SD)	120 mg LY2951742 (SD)	300 mg LY2951742 (SD)	300 mg LY2951742 Q4W
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2951742	775 ± 27	4270 ± 58	18000 ± 21	41400 ± 18	36300 ± 42

SecondaryPharmacokinetics (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.

Time frame:: Day 1: Predose, 8 hr and 24 hour postdose
Reported as:: Geometric mean · ng*hr/mL

Pharmacokinetics (PK): Area Under the Concentration Curve, Zero to Infinity ( AUC[0-∞])
ng*hr/mL	5 mg LY2951742 (SD)	50 mg LY2951742 (SD)	120 mg LY2951742 (SD)	300 mg LY2951742 (SD)	300 mg LY2951742 Q4W, Day 57
Pharmacokinetics (PK): Area Under the Concentration Curve, Zero to Infinity ( AUC[0-∞])	27600 ± 24	173000 ± 51	733000 ± 38	1520000 ± 33	757000 ± 41

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo (SD)	—	0/8 (0%)	6/8 (75%)
5 mg LY2951742 Single Dose (SD)	—	0/6 (0%)	5/6 (83.3%)
50 mg LY2951742 (SD)	—	0/6 (0%)	5/6 (83.3%)
120 mg LY2951742 (SD)	—	0/7 (0%)	6/7 (85.7%)
300 mg LY2951742 (SD)	—	0/8 (0%)	8/8 (100%)
Placebo Q4W	—	0/2 (0%)	2/2 (100%)
300 mg LY2951742 Q4W	—	0/8 (0%)	7/8 (87.5%)

Most frequent other events

Showing 10 of 28

Most frequent other events
Event	Placebo (SD)	5 mg LY2951742 Single Dose (SD)	50 mg LY2951742 (SD)	120 mg LY2951742 (SD)	300 mg LY2951742 (SD)	Placebo Q4W	300 mg LY2951742 Q4W
Injection site erythemaGeneral disorders	3/8	5/6	4/6	2/7	6/8	2/2	6/8
Injection site haemorrhageGeneral disorders	0/8	0/6	0/6	0/7	1/8	2/2	4/8
Injection site reactionGeneral disorders	2/8	0/6	1/6	1/7	1/8	0/2	5/8
Dermatitis contactSkin and subcutaneous tissue disorders	0/8	0/6	0/6	1/7	0/8	0/2	5/8
Viral infectionInfections and infestations	0/8	0/6	0/6	0/7	0/8	1/2	0/8
Neck painMusculoskeletal and connective tissue disorders	1/8	0/6	0/6	2/7	0/8	0/2	0/8
Injection site painGeneral disorders	0/8	0/6	0/6	0/7	0/8	0/2	2/8
Menopausal symptomsReproductive system and breast disorders	0/5	0/3	0/1	0/2	0/3	0/1	1/4
Oropharyngeal painRespiratory, thoracic and mediastinal disorders	2/8	0/6	0/6	0/7	0/8	0/2	0/8
Hot flushVascular disorders	0/5	0/3	0/1	0/2	0/3	0/1	1/4

Baseline characteristics

All participants who received at least 1 dose of study drug.

Age, Continuous
Age, Continuous(years)	Placebo (SD)	5 mg LY2951742 Single Dose (SD)	50 mg LY2951742 (SD)	120 mg LY2951742 (SD)	300 mg LY2951742 (SD)	Placebo Q4W	300 mg LY2951742 Q4W	Total
Mean	43.9 ± 11.6	38.8 ± 9.9	42.7 ± 12.2	34.6 ± 11.0	35.5 ± 10.3	NA ± NA	44.8 ± 11.0	40.0 ± 11.0

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo (SD)	5 mg LY2951742 Single Dose (SD)	50 mg LY2951742 (SD)	120 mg LY2951742 (SD)	300 mg LY2951742 (SD)	Placebo Q4W	300 mg LY2951742 Q4W	Total
Female	5	3	1	2	3	1	4	19
Male	3	3	5	5	5	1	4	26

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Placebo (SD)	5 mg LY2951742 Single Dose (SD)	50 mg LY2951742 (SD)	120 mg LY2951742 (SD)	300 mg LY2951742 (SD)	Placebo Q4W	300 mg LY2951742 Q4W	Total
Hispanic or Latino	0	0	0	1	0	1	1	3
Not Hispanic or Latino	8	6	6	6	8	1	7	42
Unknown or Not Reported	0	0	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Placebo (SD)	5 mg LY2951742 Single Dose (SD)	50 mg LY2951742 (SD)	120 mg LY2951742 (SD)	300 mg LY2951742 (SD)	Placebo Q4W	300 mg LY2951742 Q4W	Total
American Indian or Alaska Native	0	0	0	0	0	0	0	0
Asian	4	3	3	4	5	1	5	25
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0
Black or African American	0	0	0	0	0	0	0	0
White	4	3	3	3	3	1	3	20
More than one race	0	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Placebo (SD)	5 mg LY2951742 Single Dose (SD)	50 mg LY2951742 (SD)	120 mg LY2951742 (SD)	300 mg LY2951742 (SD)	Placebo Q4W	300 mg LY2951742 Q4W	Total
United States	8	6	6	7	8	2	8	45

Study locations

1 site

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

References and documents

Publications

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. PubMed 31482569 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02104765
Lead sponsor: Eli Lilly and Company
Responsible party: Sponsor
First posted: Apr 4, 2014
Start date: Jun 2014
Primary completion: Jan 2015
Completion: Jan 2015
Results posted: Jun 14, 2019
Last update: Jun 14, 2019

Study contacts

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)

study director · Eli Lilly and Company

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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