Galcanezumab
BiologicalAdministered SC
Other names: LY2951742
NCT Number: NCT02836613
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Covance Clinical Research Inc, Daytona Beach, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered SC
Other names: LY2951742
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
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
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)
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])
Eli Lilly and Company
Industry
Pharmacokinetics and Pharmacodynamics of LY2951742 (Galcanezumab) in Healthy Subjects Following Subcutaneous Administration of LY2951742 (Galcanezumab) Solution in a Prefilled Syringe or an Autoinjector
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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