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A Study of Galcanezumab in Healthy Participants

NCT02576951 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2019-02-26

Study results available
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Summary

The purposes of this study are:

* To evaluate tolerability of the Galcanezumab solution injectable formulation (Part A)
* To measure how much of the Galcanezumab lyophilized (freeze dried) injectable formulation is absorbed into the blood stream and how long it takes the body to get rid of it compared to the Galcanezumab solution injectable formulation after a single injection under the skin (subcutaneous \[SC\]) (Part B).

Information about any side effects that may occur will also be collected. Each part of the study will last about six months. Participants may only enroll in one part.

Conditions

  • Healthy

Interventions

DRUG

Galcanezumab

Administered SC

DRUG

Placebo

Administered SC

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-19
Primary Completion
2016-09-03
Completion
2018-01-08

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02576951 on ClinicalTrials.gov