A Study of Galcanezumab in Healthy Participants.
Pharmacokinetics and Pharmacodynamics of LY2951742 (Galcanezumab) in Healthy Subjects Following Subcutaneous Administration of LY2951742 (Galcanezumab) Solution in a Prefilled Syringe or an Autoinjector
2 other identifiers
interventional
160
1 country
3
Brief Summary
The main purpose of this study is to evaluate how much galcanezumab gets into the body after it is given as an injection just under the skin by two different devices. This study will measure how much galcanezumab reaches the blood stream and will test how it affects calcitonin-gene related peptide (CGRP) in blood. Information about any side effects that may occur will be collected. The study will last about 20 weeks for each participant. Screening is required within 45 days prior to the start of the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Jul 2016
Longer than P75 for phase_1 healthy
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 15, 2016
CompletedFirst Posted
Study publicly available on registry
July 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2017
CompletedResults Posted
Study results publicly available
March 13, 2019
CompletedMarch 13, 2019
December 1, 2017
8 months
July 15, 2016
October 19, 2018
March 9, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab
8, 24, 48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688 and 3360 hours post dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf] of Galcanezumab
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-inf\] of Galcanezumab
8, 24, 48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688 and 3360 hours post dose
Secondary Outcomes (2)
Pharmacodynamics (PD): Maximum Observed CGRP Concentration (Cmax)
Pre dose, 24,48,96,120,168,264,336,504,672,1008,1244,1680,2016,2688, and 3360 hours post dose
Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration of CGRP (AUC[0-tlast, CGRP])
Pre dose, 24,48,96,120,168,264,336,504,672,1008,1244,1680,2016,2688, and 3360 hours post dose
Study Arms (2)
Galcanezumab Reference
ACTIVE COMPARATORSingle dose of 240 milligrams (mg) galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe (PFS).
Galcanezumab Test
EXPERIMENTALSingle dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- Overtly healthy as determined by medical history and physical examination
- Have a body mass index (BMI) between 19.0 and 35.0 kilogram per meter square (kg/m²)
- Have clinical laboratory test results within normal reference range for the investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
You may not qualify if:
- Have previously completed or withdrawn from this study or any other study investigating galcanezumab, and have previously received galcanezumab
- Have allergies to either humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
- Have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Covance Clinical Research Inc
Daytona Beach, Florida, 32117, United States
Covance Clinical Research Inc
Evansville, Indiana, 47710, United States
Covance
Dallas, Texas, 75247, United States
Related Publications (1)
Stauffer VL, Sides R, Lanteri-Minet M, Kielbasa W, Jin Y, Selzler KJ, Tepper SJ. Comparison between prefilled syringe and autoinjector devices on patient-reported experiences and pharmacokinetics in galcanezumab studies. Patient Prefer Adherence. 2018 Sep 17;12:1785-1795. doi: 10.2147/PPA.S170636. eCollection 2018.
PMID: 30271122DERIVED
MeSH Terms
Interventions
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
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2016
First Posted
July 19, 2016
Study Start
July 1, 2016
Primary Completion
February 27, 2017
Study Completion
November 9, 2017
Last Updated
March 13, 2019
Results First Posted
March 13, 2019
Record last verified: 2017-12