Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
178 participants
INTERVENTIONAL
2015-10-19
2018-01-08
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Galcanezumab Solution Formulation-Part A
Galcanezumab solution formulation in a prefilled syringe given SC once.
Galcanezumab
Administered SC
Placebo-Part A
Placebo in a prefilled syringe given SC once.
Placebo
Administered SC
Galcanezumab Lyophilized Formulation-Part B
Galcanezumab lyophilized (freeze dried) formulation given SC once.
Galcanezumab
Administered SC
Galcanezumab Solution Formulation-Part B
Galcanezumab solution formulation in a prefilled syringe given SC once.
Galcanezumab
Administered SC
Interventions
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Galcanezumab
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a body mass index of 19.0 to 35.0 kilograms per meter square (kg/m²), inclusive
Exclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Covance
Dallas, Texas, United States
Countries
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References
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Kielbasa W, Quinlan T. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine. J Clin Pharmacol. 2020 Feb;60(2):229-239. doi: 10.1002/jcph.1511. Epub 2019 Sep 4.
Other Identifiers
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I5Q-MC-CGAO
Identifier Type: OTHER
Identifier Source: secondary_id
16084
Identifier Type: -
Identifier Source: org_study_id
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