Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Galcanezumab in Healthy Participants.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02836613
Recruitment Status : Completed
First Posted : July 19, 2016
Results First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Healthy
Intervention Biological: Galcanezumab
Enrollment 160
Recruitment Details Open label, randomized, parallel group with study drug administration on Day 1 and up to 20 weeks blood sampling.
Pre-assignment Details  
Arm/Group Title Galcanezumab Pre Filled Syringe (PFS) Galcanezumab Autoinjector
Hide Arm/Group Description Single dose of 240 mg galcanezumab administered subcutaneously (SC) by manual prefilled syringe. Single dose of 240 mg galcanezumab administered SC by autoinjector.
Period Title: Overall Study
Started 80 80
Completed 79 77
Not Completed 1 3
Reason Not Completed
Accidental drowning             1             0
Lost to Follow-up             0             1
Withdrawal by Subject             0             2
Arm/Group Title Galcanezumab Pre Filled Syringe (PFS) Galcanezumab Autoinjector Total
Hide Arm/Group Description Single dose of 240 mg galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe. Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector. Total of all reporting groups
Overall Number of Baseline Participants 80 80 160
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants 80 participants 160 participants
38.6  (11.9) 38.3  (11.5) 38.4  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 80 participants 160 participants
Female 40 41 81
Male 40 39 79
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 80 participants 160 participants
Hispanic or Latino 14 17 31
Not Hispanic or Latino 66 63 129
Unknown or Not Reported 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 80 participants 160 participants
American Indian or Alaska Native 1 1 2
Asian 1 0 1
Native Hawaiian or Other Pacific Islander 1 0 1
Black or African American 33 31 64
White 43 46 89
More than one race 1 2 3
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 80 participants 80 participants 160 participants
80
 100.0%
80
 100.0%
160
 100.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 80 participants 80 participants 160 participants
78.39  (14.34) 81.61  (13.72) 80.00  (14.08)
1.Primary Outcome
Title Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab
Hide Description Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab
Time Frame 8, 24, 48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688 and 3360 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug and had evaluable PK data.
Arm/Group Title Galcanezumab Pre Filled Syringe (PFS) Galcanezumab Autoinjector
Hide Arm/Group Description:
Single dose of 240 mg galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe.
Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector.
Overall Number of Participants Analyzed 74 75
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms per milliliter (ug/mL)
31.5
(40%)
32.3
(33%)
2.Primary Outcome
Title Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf] of Galcanezumab
Hide Description Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf] of Galcanezumab
Time Frame 8, 24, 48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688 and 3360 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug and had evaluable PK data.
Arm/Group Title Galcanezumab Pre Filled Syringe (PFS) Galcanezumab Autoinjector
Hide Arm/Group Description:
Single dose of 240 mg galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe.
Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector.
Overall Number of Participants Analyzed 74 75
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: day*ug/mL
1170
(35%)
1110
(35%)
3.Secondary Outcome
Title Pharmacodynamics (PD): Maximum Observed CGRP Concentration (Cmax)
Hide Description Pharmacodynamics (PD): Maximum Observed CGRP Concentration (Cmax)
Time Frame Pre dose, 24,48,96,120,168,264,336,504,672,1008,1244,1680,2016,2688, and 3360 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug and had evaluable Cmax CGRP PD data.
Arm/Group Title Galcanezumab Pre Filled Syringe (PFS) Galcanezumab Autoinjector
Hide Arm/Group Description:
Single dose of 240 mg galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe.
Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector.
Overall Number of Participants Analyzed 74 75
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter (ng/mL)
3.11
(41%)
3.13
(48%)
4.Secondary Outcome
Title Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration of CGRP (AUC[0-tlast, CGRP])
Hide Description Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve from Time Zero to Time T, Where T is the Last Time Point with a Measurable Concentration of CGRP (AUC[0-tlast, CGRP])
Time Frame Pre dose, 24,48,96,120,168,264,336,504,672,1008,1244,1680,2016,2688, and 3360 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug and had evaluable AUC[0-tlast, CGRP] PD data.
Arm/Group Title Galcanezumab Pre Filled Syringe (PFS) Galcanezumab Autoinjector
Hide Arm/Group Description:
Single dose of 240 mg galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe.
Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector.
Overall Number of Participants Analyzed 66 63
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: day*ng/mL
242
(50%)
242
(58%)
Time Frame up to 8 months
Adverse Event Reporting Description All participants who received at least 1 dose of study drug.
 
Arm/Group Title Galcanezumab Pre Filled Syringe (PFS) Galcanezumab Autoinjector
Hide Arm/Group Description Single dose of 240 mg galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe. Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector.
All-Cause Mortality
Galcanezumab Pre Filled Syringe (PFS) Galcanezumab Autoinjector
Affected / at Risk (%) Affected / at Risk (%)
Total   1/80 (1.25%)      0/80 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Galcanezumab Pre Filled Syringe (PFS) Galcanezumab Autoinjector
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/80 (1.25%)      1/80 (1.25%)    
General disorders     
Drowning  1  1/80 (1.25%)  1 0/80 (0.00%)  0
Injury, poisoning and procedural complications     
Concussion  1  0/80 (0.00%)  0 1/80 (1.25%)  1
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Galcanezumab Pre Filled Syringe (PFS) Galcanezumab Autoinjector
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/80 (33.75%)      38/80 (47.50%)    
Eye disorders     
Eye irritation  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Gastrointestinal disorders     
Abdominal pain  1  1/80 (1.25%)  1 0/80 (0.00%)  0
Diarrhoea  1  1/80 (1.25%)  1 2/80 (2.50%)  2
Nausea  1  1/80 (1.25%)  1 1/80 (1.25%)  1
Vomiting  1  1/80 (1.25%)  1 1/80 (1.25%)  1
General disorders     
Influenza like illness  1  1/80 (1.25%)  1 0/80 (0.00%)  0
Injection site bruising  1  2/80 (2.50%)  3 3/80 (3.75%)  3
Injection site erythema  1  2/80 (2.50%)  2 4/80 (5.00%)  6
Injection site induration  1  1/80 (1.25%)  1 2/80 (2.50%)  3
Injection site pain  1  2/80 (2.50%)  2 10/80 (12.50%)  14
Injection site pruritus  1  1/80 (1.25%)  1 2/80 (2.50%)  3
Injection site swelling  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Non-cardiac chest pain  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Vessel puncture site bruise  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Immune system disorders     
Seasonal allergy  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Infections and infestations     
Gastroenteritis  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Influenza  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Oral herpes  1  0/80 (0.00%)  0 2/80 (2.50%)  2
Pharyngitis  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Rhinitis  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Sinusitis  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Tinea pedis  1  1/80 (1.25%)  1 0/80 (0.00%)  0
Upper respiratory tract infection  1  4/80 (5.00%)  4 6/80 (7.50%)  6
Viral upper respiratory tract infection  1  1/80 (1.25%)  1 0/80 (0.00%)  0
Injury, poisoning and procedural complications     
Animal bite  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Arthropod bite  1  1/80 (1.25%)  1 0/80 (0.00%)  0
Concussion  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Contusion  1  1/80 (1.25%)  1 2/80 (2.50%)  2
Face injury  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Fall  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Hand fracture  1  1/80 (1.25%)  1 0/80 (0.00%)  0
Muscle strain  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Procedural dizziness  1  1/80 (1.25%)  1 0/80 (0.00%)  0
Skin abrasion  1  2/80 (2.50%)  2 1/80 (1.25%)  2
Skull fracture  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Tooth fracture  1  1/80 (1.25%)  1 0/80 (0.00%)  0
Investigations     
White blood cells urine positive  1  1/80 (1.25%)  1 0/80 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/80 (0.00%)  0 1/80 (1.25%)  2
Back pain  1  4/80 (5.00%)  5 1/80 (1.25%)  1
Muscle spasms  1  1/80 (1.25%)  1 0/80 (0.00%)  0
Musculoskeletal pain  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Neck pain  1  0/80 (0.00%)  0 2/80 (2.50%)  2
Pain in extremity  1  1/80 (1.25%)  2 1/80 (1.25%)  1
Tendonitis  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Nervous system disorders     
Dizziness  1  1/80 (1.25%)  1 2/80 (2.50%)  2
Headache  1  5/80 (6.25%)  5 9/80 (11.25%)  11
Lethargy  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Neuritis  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Psychiatric disorders     
Aggression  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Renal and urinary disorders     
Micturition urgency  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Reproductive system and breast disorders     
Dysmenorrhoea  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Metrorrhagia  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchial hyperreactivity  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Cough  1  1/80 (1.25%)  1 1/80 (1.25%)  1
Epistaxis  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Nasal congestion  1  0/80 (0.00%)  0 2/80 (2.50%)  2
Paranasal sinus discomfort  1  1/80 (1.25%)  1 0/80 (0.00%)  0
Rhinitis allergic  1  1/80 (1.25%)  1 0/80 (0.00%)  0
Wheezing  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Skin and subcutaneous tissue disorders     
Hand dermatitis  1  0/80 (0.00%)  0 1/80 (1.25%)  1
Skin plaque  1  1/80 (1.25%)  1 0/80 (0.00%)  0
Urticaria  1  0/80 (0.00%)  0 1/80 (1.25%)  1
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02836613     History of Changes
Other Study ID Numbers: 16203
I5Q-MC-CGAQ ( Other Identifier: Eli Lilly and Company )
First Submitted: July 15, 2016
First Posted: July 19, 2016
Results First Submitted: October 19, 2018
Results First Posted: March 13, 2019
Last Update Posted: March 13, 2019