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A Study of Galcanezumab in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02576951
Recruitment Status : Completed
First Posted : October 15, 2015
Results First Posted : February 26, 2019
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:

The purposes of this study are:

  • To evaluate tolerability of the Galcanezumab solution injectable formulation (Part A)
  • To measure how much of the Galcanezumab lyophilized (freeze dried) injectable formulation is absorbed into the blood stream and how long it takes the body to get rid of it compared to the Galcanezumab solution injectable formulation after a single injection under the skin (subcutaneous [SC]) (Part B).

Information about any side effects that may occur will also be collected. Each part of the study will last about six months. Participants may only enroll in one part.


Condition or disease Intervention/treatment Phase
Healthy Drug: Galcanezumab Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Tolerability, Pharmacokinetics and Pharmacodynamics of LY2951742 in Healthy Subjects Following a Subcutaneous Administration of a Lyophilized Formulation or a Solution Formulation
Actual Study Start Date : October 19, 2015
Actual Primary Completion Date : September 3, 2016
Actual Study Completion Date : January 8, 2018

Arm Intervention/treatment
Experimental: Galcanezumab Solution Formulation-Part A
Galcanezumab solution formulation in a prefilled syringe given SC once.
Drug: Galcanezumab
Administered SC
Other Name: LY2951742

Placebo Comparator: Placebo-Part A
Placebo in a prefilled syringe given SC once.
Drug: Placebo
Administered SC

Experimental: Galcanezumab Lyophilized Formulation-Part B
Galcanezumab lyophilized (freeze dried) formulation given SC once.
Drug: Galcanezumab
Administered SC
Other Name: LY2951742

Experimental: Galcanezumab Solution Formulation-Part B
Galcanezumab solution formulation in a prefilled syringe given SC once.
Drug: Galcanezumab
Administered SC
Other Name: LY2951742




Primary Outcome Measures :
  1. Part A: Number of Participants With an Injection Site Adverse Event [ Time Frame: Part A: Predose through 48 hours post dose ]
    If an injection site reaction is present, it will be fully characterized (including erythema, induration, pain, itching). A summary of other nonserious adverse event (AE), and all serious adverse events (SAE), regardless of causality, is located in the reported adverse events section.

  2. Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity of Galcanezumab [ Time Frame: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose ]
    Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) from Time Zero to Infinity of Galcanezumab.

  3. Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab [ Time Frame: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose ]
    Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab.


Secondary Outcome Measures :
  1. Part A: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP) [ Time Frame: Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose ]
    Part A: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP).

  2. Part A: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC [0 to Tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP) [ Time Frame: Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose ]
    Part A: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC [0 to Tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP).

  3. Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP [ Time Frame: Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose ]
    Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP.

  4. Part B: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP) [ Time Frame: Part B: Predose, 8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose ]
    Part B: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP).

  5. Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP) [ Time Frame: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose ]
    Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve from time zero to tlast (AUC[0-tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP).

  6. Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP [ Time Frame: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose ]
    Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma 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:

  • Male and female healthy participants
  • Have a body mass index of 19.0 to 35.0 kilograms per meter square (kg/m²), inclusive

Exclusion Criteria:

- Currently smoke in excess of 5 cigarettes/day


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): NCT02576951


Locations
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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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02576951    
Other Study ID Numbers: 16084
I5Q-MC-CGAO ( Other Identifier: Eli Lilly and Company )
First Posted: October 15, 2015    Key Record Dates
Results First Posted: February 26, 2019
Last Update Posted: February 26, 2019
Last Verified: February 2018