NCT02576951

A Study of Galcanezumab in Healthy Participants

Completed Phase 1 Results posted Last updated 26 February 2019

What this trial tests

Phase 1 trial testing Galcanezumab in Healthy in 178 participants. Completed in 8 January 2018.

Timeline

19 October 2015

Primary endpoint
3 September 2016

8 January 2018

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	178
Start date	19 October 2015
Primary completion	3 September 2016
Estimated completion	8 January 2018
Sites	1 location across United States

Drugs / interventions tested

• Galcanezumab (GALCANEZUMAB) — full drug profile →
• Placebo

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part A: Number of Participants With an Injection Site Adverse Event Primary · 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.

Group	Value	95% CI
240 mg Galcanezumab - Part A	3
Placebo - Part A	0

Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity of Galcanezumab Primary · 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.

Group	Value	95% CI
300mg Galcanezumab Solution - Part B	1490	± 31
300 mg Galcanezumab Lyophilized - Part B	1670	± 32

Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab Primary · 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.

Group	Value	95% CI
300 mg Galcanezumab Solution - Part B	38	± 30
300 mg Galcanezumab Lyophilized - Part B	42.4	± 28

Part A: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP) Secondary · 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).

Group	Value	95% CI
240 mg Galcanezumab - Part A	56.01	28.04 – 112.01

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) Secondary · 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).

Group	Value	95% CI
240 mg Galcanezumab - Part A	231	± 48

Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP Secondary · 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.

Group	Value	95% CI
240 mg Galcanezumab - Part A	2.64	± 34

Part B: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP) Secondary · 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).

Group	Value	95% CI
300 mg Galcanezumab Solution - Part B	41.93	20.93 – 84.03
300 mg Galcanezumab Lyophilized - Part B	41.95	13.92 – 83.95

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) Secondary · 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).

Group	Value	95% CI
300 mg Galcanezumab Solution - Part B	169	± 50
300 mg Galcanezumab Lyophilized - Part B	192	± 50

Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP Secondary · 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.

Group	Value	95% CI
300 mg Galcanezumab Solution - Part B	2.19	± 36
300 mg Galcanezumab Lyophilized - Part B	2.38	± 34

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 20 Weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Galcanezumab 240 mg - Part A

Serious: 0/15 (0%)

Deaths: 0/15

Placebo - Part A

Serious: 1/3 (33%)

Deaths: 0/3

Galcanezumab 300 mg Lyophilized - Part B

Serious: 1/80 (1%)

Deaths: 0/80

Galcanezumab 300 mg Solution - Part B

Serious: 0/80 (0%)

Deaths: 0/80

Serious adverse events (2 terms)

Reaction	System	Galcanezumab 240 mg - Part A	Placebo - Part A	Galcanezumab 300 mg Lyophi…	Galcanezumab 300 mg Soluti…
Atrial fibrillation	Cardiac disorders	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—

Other adverse events (68 terms — click to expand)

Reaction	System	Galcanezumab 240 mg - Part A	Placebo - Part A	Galcanezumab 300 mg Lyophi…	Galcanezumab 300 mg Soluti…
Headache	Nervous system disorders	—	—	—	—
Injection site pain	General disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Throat irritation	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—	—
Ear discomfort	Ear and labyrinth disorders	—	—	—	—
Ear pain	Ear and labyrinth disorders	—	—	—	—
Lacrimation increased	Eye disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Dental discomfort	Gastrointestinal disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—
Chest pain	General disorders	—	—	—	—
Facial pain	General disorders	—	—	—	—
Injection site erythema	General disorders	—	—	—	—
Injection site pruritus	General disorders	—	—	—	—
Injection site swelling	General disorders	—	—	—	—
Pain	General disorders	—	—	—	—
Vessel puncture site pain	General disorders	—	—	—	—
Vessel puncture site reaction	General disorders	—	—	—	—
Seasonal allergy	Immune system disorders	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
Fungal infection	Infections and infestations	—	—	—	—
Furuncle	Infections and infestations	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Laryngitis	Infections and infestations	—	—	—	—
Oral herpes	Infections and infestations	—	—	—	—
Tonsillitis	Infections and infestations	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—
Laceration	Injury, poisoning and procedural complications	—	—	—	—

Most-reported serious reactions: Atrial fibrillation, Cellulitis.

Data from ClinicalTrials.gov NCT02576951 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Spotlight on Anti-CGRP Monoclonal Antibodies in Migraine: The Clinical Evidence to Date.
   Pellesi L, Guerzoni S, Pini LA. · · 2017 · cited 48× · PMID 28409893 · DOI 10.1002/cpdd.345
2. The Biology of Monoclonal Antibodies: Focus on Calcitonin Gene-Related Peptide for Prophylactic Migraine Therapy.
   Raffaelli B, Reuter U. · · 2018 · cited 43× · PMID 29616494 · DOI 10.1007/s13311-018-0622-7
3. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine.
   Kielbasa W, Quinlan T. · · 2020 · cited 25× · PMID 31482569 · DOI 10.1002/jcph.1511