A Study of Galcanezumab in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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Tolerability, Pharmacokinetics and Pharmacodynamics of LY2951742 in Healthy Subjects Following a Subcutaneous Administration of a Lyophilized Formulation or a Solution Formulation

Conditions
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Healthy

Intervention / Treatment
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* Drug: Galcanezumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Galcanezumab Solution Formulation-Part A<br>Galcanezumab solution formulation in a prefilled syringe given SC once. | Drug: Galcanezumab<br>* Administered SC<br>* Other names: LY2951742;|
| Placebo Comparator: Placebo-Part A<br>Placebo in a prefilled syringe given SC once. | Drug: Placebo<br>* Administered SC<br>|
| Experimental: Galcanezumab Lyophilized Formulation-Part B<br>Galcanezumab lyophilized (freeze dried) formulation given SC once. | Drug: Galcanezumab<br>* Administered SC<br>* Other names: LY2951742;|
| Experimental: Galcanezumab Solution Formulation-Part B<br>Galcanezumab solution formulation in a prefilled syringe given SC once. | Drug: Galcanezumab<br>* Administered SC<br>* Other names: LY2951742;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A: Number of Participants With an Injection Site Adverse Event | If an injection site reaction is present, it will be fully characterized (including erythema, induration, pain, itching). A summary of other nonserious adverse event (AE), and all serious adverse events (SAE), regardless of causality, is located in the reported adverse events section. | Part A: Predose through 48 hours post dose | 
| Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity of Galcanezumab | Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) from Time Zero to Infinity of Galcanezumab. | Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose | 
| Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab | Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab. | Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP) | Part A: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP). | Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose | 
| Part A: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC [0 to Tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP) | Part A: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC [0 to Tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP). | Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose | 
| Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP | Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP. | Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose | 
| Part B: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP) | Part B: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP). | Part B: Predose, 8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose | 
| Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP) | Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve from time zero to tlast (AUC[0-tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP). | Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose | 
| Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP | Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP. | Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose |