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OpenTrials
Completed

NCT Number: NCT02836613

A Study of Galcanezumab in Healthy Participants.

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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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Inc, Daytona Beach, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Have previously completed or withdrawn from this study or any other study investigating galcanezumab, and have previously received galcanezumab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

Treatment and study plan

Galcanezumab

Biological

Administered SC

Other names: LY2951742

Primary outcomes

  1. 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): Maximum Concentration (Cmax) of Galcanezumab

  2. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf] 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

Secondary outcomes

  1. 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): Maximum Observed CGRP Concentration (Cmax)

  2. 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])

    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])

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Pharmacokinetics and Pharmacodynamics of LY2951742 (Galcanezumab) in Healthy Subjects Following Subcutaneous Administration of LY2951742 (Galcanezumab) Solution in a Prefilled Syringe or an Autoinjector

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 19, 2016
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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