A Study of Galcanezumab in Healthy Participants.
- Conditions
- Healthy
- Interventions
- Biological: Galcanezumab
- Registration Number
- NCT02836613
- Lead Sponsor
- Eli Lilly and Company
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- 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
- Have previously completed or withdrawn from this study or any other study investigating galcanezumab, and have previously received galcanezumab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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Galcanezumab Test Galcanezumab Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector. Galcanezumab Reference Galcanezumab Single dose of 240 milligrams (mg) galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe (PFS).
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab 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 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
- Secondary Outcome Measures
Name Time Method Pharmacodynamics (PD): Maximum Observed CGRP Concentration (Cmax) 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]) 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\[0-tlast, CGRP\])
Trial Locations
- Locations (2)
Covance Clinical Research Inc
🇺🇸Evansville, Indiana, United States
Covance
🇺🇸Dallas, Texas, United States