A Study of Galcanezumab in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Galcanezumab; Drug: Placebo

• Registration Number: NCT02576951
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-14
• Study First Submitted QC: 2015-10-14
• Study First Posted: 2015-10-15
• Study Start: 2015-10-19
• Primary Completion: 2016-09-03
• Study Completion: 2018-01-08
• Status Verified: 2018-02
• Results First Submitted: 2018-10-19
• Results First Submitted QC: 2018-10-19
• Last Update Submitted: 2018-10-19
• Results First Posted: 2019-02-26
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Galcanezumab Lyophilized Formulation-Part B	Galcanezumab	Galcanezumab lyophilized (freeze dried) formulation given SC once.
Placebo-Part A	Placebo	Placebo in a prefilled syringe given SC once.
Galcanezumab Solution Formulation-Part B	Galcanezumab	Galcanezumab solution formulation in a prefilled syringe given SC once.
Galcanezumab Solution Formulation-Part A	Galcanezumab	Galcanezumab solution formulation in a prefilled syringe given SC once.

Primary Outcome Measures

Name	Time	Method
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	Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab.
Part A: Number of Participants With an Injection Site Adverse Event	Part A: Predose through 48 hours post dose	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 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 (PK): Area Under the Concentration Versus Time Curve (AUC) from Time Zero to Infinity of Galcanezumab.

Secondary Outcome Measures

Name	Time	Method
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): 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): 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 A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma 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): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (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	Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma 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): Time to maximum concentration (tmax) 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): Area Under the Concentration Versus Time Curve from time zero to tlast (AUC\[0-tlast\]) of Plasma Calcitonin Gene Related Peptide (CGRP).

Trial Locations

Locations (1)

Covance; 🇺🇸 Dallas, Texas, United States