CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 160 enrolled
Drug / intervention
Galcanezumabbiological
Likely dose
Galcanezumab administered subcutaneously (specific dose not stated in arms or interventions)AI-extracted
Key inclusion· 3
  • ✓Overtly healthy as determined by medical history and physical examination
  • ✓Body mass index (BMI) between 19.0 and 35.0 kg/m²
  • ✓Clinical laboratory test results within normal reference range or acceptable deviations judged not clinically significant by investigator
Key exclusion· 4
  • ✕Previously received galcanezumab or completed/withdrawn from any galcanezumab study
  • ✕Allergies to humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
  • ✕Intend to use over-the-counter or prescription medication within 7 days prior to dosing and during study (except stable hormone replacement therapy)
  • ✕History of lymphoma, leukemia, or any malignancy within past 5 years (except resected skin basal cell or squamous epithelial carcinomas with no metastatic disease for ≥3 years)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02836613
NCT02836613Phase 1Completed
CompareCT.gov

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

Eli Lilly and Company·interventional·Posted Jul 19, 2016·Updated Mar 13, 2019

In Brief

A Phase 1 clinical trial evaluating Galcanezumab for Healthy. Completed, enrolled 160 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 19, 2016
Enrollment StartJul 1, 2016
Primary CompletionFeb 27, 2017
Study CompletionNov 9, 2017
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.0 years ago

Interventions

Galcanezumabbiological

Administered SC