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A Study of Galcanezumab in Healthy Participants

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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

Study Description
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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

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Contacts and Locations
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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