A Study of Galcanezumab in Healthy Participants.
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/15/2019 |
| Start Date: | July 2016 |
| End Date: | November 9, 2017 |
Pharmacokinetics and Pharmacodynamics of LY2951742 (Galcanezumab) in Healthy Subjects Following Subcutaneous Administration of LY2951742 (Galcanezumab) Solution in a Prefilled Syringe or an Autoinjector
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Have previously completed or withdrawn from this study or any other study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
We found this trial at
3
sites
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Daytona Beach, Florida 32117
Principal Investigator: Melanie Fein
Phone: 386-366-6406
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Evansville, Indiana 47710
Principal Investigator: Kelly M Whitehurst
Phone: 812-474-5016
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