A Study of Galcanezumab in Healthy Participants

NCT02576951 | Completed Phase 1 Results

• 2 other identifiers: 16084I5Q-MC-CGAO
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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: 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: 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: 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: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose

Study Arms (4)

Galcanezumab Solution Formulation-Part A

EXPERIMENTAL

Galcanezumab solution formulation in a prefilled syringe given SC once.

Drug: Galcanezumab

Placebo-Part A

PLACEBO COMPARATOR

Placebo in a prefilled syringe given SC once.

Drug: Placebo

Galcanezumab Lyophilized Formulation-Part B

EXPERIMENTAL

Galcanezumab lyophilized (freeze dried) formulation given SC once.

Drug: Galcanezumab

Galcanezumab Solution Formulation-Part B

EXPERIMENTAL

Galcanezumab solution formulation in a prefilled syringe given SC once.

Drug: Galcanezumab

Interventions

Galcanezumab DRUG

Administered SC

Also known as: LY2951742

Galcanezumab Lyophilized Formulation-Part B; Galcanezumab Solution Formulation-Part A; Galcanezumab Solution Formulation-Part B

Placebo DRUG

Administered SC

Placebo-Part A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- Currently smoke in excess of 5 cigarettes/day

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance

Dallas, Texas, 75247, United States

Location

Related Publications (1)

• Kielbasa W, Quinlan T. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine. J Clin Pharmacol. 2020 Feb;60(2):229-239. doi: 10.1002/jcph.1511. Epub 2019 Sep 4.

  PMID: 31482569 DERIVED

MeSH Terms

Interventions

galcanezumab

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 15, 2015
• Study Start: October 19, 2015
• Primary Completion: September 3, 2016
• Study Completion: January 8, 2018
• Last Updated: February 26, 2019
• Results First Posted: February 26, 2019

Record last verified: 2018-02

Locations

US (1)