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A Study of Galcanezumab in Healthy Participants.

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ClinicalTrials.gov Identifier: NCT02836613
Recruitment Status : Completed
First Posted : July 19, 2016
Results First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Healthy Biological: Galcanezumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmacokinetics and Pharmacodynamics of LY2951742 (Galcanezumab) in Healthy Subjects Following Subcutaneous Administration of LY2951742 (Galcanezumab) Solution in a Prefilled Syringe or an Autoinjector
Study Start Date : July 2016
Actual Primary Completion Date : February 27, 2017
Actual Study Completion Date : November 9, 2017

Arm Intervention/treatment
Active Comparator: Galcanezumab Reference
Single dose of 240 milligrams (mg) galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe (PFS).
Biological: Galcanezumab
Administered SC
Other Name: LY2951742

Experimental: Galcanezumab Test
Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector.
Biological: Galcanezumab
Administered SC
Other Name: LY2951742




Primary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab [ Time Frame: 8, 24, 48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688 and 3360 hours post dose ]
    Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab

  2. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf] of Galcanezumab [ Time Frame: 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


Secondary Outcome Measures :
  1. Pharmacodynamics (PD): Maximum Observed CGRP Concentration (Cmax) [ Time Frame: Pre dose, 24,48,96,120,168,264,336,504,672,1008,1244,1680,2016,2688, and 3360 hours post dose ]
    Pharmacodynamics (PD): Maximum Observed CGRP Concentration (Cmax)

  2. 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]) [ Time Frame: 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])



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Intend to use over-the-counter or prescription medication within 7 days prior to dosing and during the study (especially systemic glucocorticoids, immunomodulatory drugs, drugs with propensity for dermal reactions, drugs with known hepatic toxicity, etc). Stable doses of hormone replacement therapy (HRT) are allowed for inclusion at the discretion of the investigator
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836613


Locations
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United States, Florida
Covance Clinical Research Inc
Daytona Beach, Florida, United States, 32117
United States, Indiana
Covance Clinical Research Inc
Evansville, Indiana, United States, 47710
United States, Texas
Covance
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] May 31, 2016
Statistical Analysis Plan  [PDF] July 27, 2016


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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02836613     History of Changes
Other Study ID Numbers: 16203
I5Q-MC-CGAQ ( Other Identifier: Eli Lilly and Company )
First Posted: July 19, 2016    Key Record Dates
Results First Posted: March 13, 2019
Last Update Posted: March 13, 2019
Last Verified: December 2017