A Study of Galcanezumab in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Galcanezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02576951

16084

I5Q-MC-CGAO (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 178 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female healthy participants
• Have a body mass index of 19.0 to 35.0 kilograms per meter square (kg/m²), inclusive

Exclusion criteria

• Currently smoke in excess of 5 cigarettes/day

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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178 participants in 4 patient groups, including a placebo group

Galcanezumab Solution Formulation-Part A

Experimental group

Description:

Galcanezumab solution formulation in a prefilled syringe given SC once.

Treatment:

Drug: Galcanezumab

Placebo-Part A

Placebo Comparator group

Description:

Placebo in a prefilled syringe given SC once.

Treatment:

Drug: Placebo

Galcanezumab Lyophilized Formulation-Part B

Experimental group

Description:

Galcanezumab lyophilized (freeze dried) formulation given SC once.

Treatment:

Drug: Galcanezumab

Galcanezumab Solution Formulation-Part B

Experimental group

Description:

Galcanezumab solution formulation in a prefilled syringe given SC once.

Treatment:

Drug: Galcanezumab