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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

Tracking Information
First Submitted Date  ICMJE July 15, 2016
First Posted Date  ICMJE July 19, 2016
Results First Submitted Date  ICMJE October 19, 2018
Results First Posted Date  ICMJE March 13, 2019
Last Update Posted Date March 13, 2019
Study Start Date  ICMJE July 2016
Actual Primary Completion Date February 27, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: July 15, 2016)
  • Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab [ Time Frame: 8 hours post dose through 3360 hours post dose ]
  • Pharmacokinetics: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf] of Galcanezumab [ Time Frame: 0 hours post dose through 3360 hours post dose ]
Change History Complete list of historical versions of study NCT02836613 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2019)
  • 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)
  • 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])
Original Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2016)
  • Pharmacodynamics: Maximum Observed CGRP Concentration (Cmax, CGRP) [ Time Frame: Pre dose through 3360 hours post dose ]
  • Pharmacodynamics: 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 through 3360 hours post dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Galcanezumab in Healthy Participants.
Official Title  ICMJE Pharmacokinetics and Pharmacodynamics of LY2951742 (Galcanezumab) in Healthy Subjects Following Subcutaneous Administration of LY2951742 (Galcanezumab) Solution in a Prefilled Syringe or an Autoinjector
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE Biological: Galcanezumab
Administered SC
Other Name: LY2951742
Study Arms  ICMJE
  • Active Comparator: Galcanezumab Reference
    Single dose of 240 milligrams (mg) galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe (PFS).
    Intervention: Biological: Galcanezumab
  • Experimental: Galcanezumab Test
    Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector.
    Intervention: Biological: Galcanezumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2016)
160
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 9, 2017
Actual Primary Completion Date February 27, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02836613
Other Study ID Numbers  ICMJE 16203
I5Q-MC-CGAQ ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP