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| ID | Type | Description | Link |
|---|---|---|---|
| I5Q-MC-CGAQ | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate how much galcanezumab gets into the body after it is given as an injection just under the skin by two different devices. This study will measure how much galcanezumab reaches the blood stream and will test how it affects calcitonin-gene related peptide (CGRP) in blood. Information about any side effects that may occur will be collected. The study will last about 20 weeks for each participant. Screening is required within 45 days prior to the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galcanezumab Reference | Active Comparator | Single dose of 240 milligrams (mg) galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe (PFS). |
|
| Galcanezumab Test | Experimental | Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galcanezumab | Biological | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab | 8, 24, 48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688 and 3360 hours post dose |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf] of Galcanezumab | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf] of Galcanezumab | 8, 24, 48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688 and 3360 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (PD): Maximum Observed CGRP Concentration (Cmax) | Pharmacodynamics (PD): Maximum Observed CGRP Concentration (Cmax) | Pre dose, 24,48,96,120,168,264,336,504,672,1008,1244,1680,2016,2688, and 3360 hours post dose |
| 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]) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Inc | Daytona Beach | Florida | 32117 | United States | ||
| Covance Clinical Research Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30271122 | Derived | Stauffer VL, Sides R, Lanteri-Minet M, Kielbasa W, Jin Y, Selzler KJ, Tepper SJ. Comparison between prefilled syringe and autoinjector devices on patient-reported experiences and pharmacokinetics in galcanezumab studies. Patient Prefer Adherence. 2018 Sep 17;12:1785-1795. doi: 10.2147/PPA.S170636. eCollection 2018. |
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Open label, randomized, parallel group with study drug administration on Day 1 and up to 20 weeks blood sampling.
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| ID | Title | Description |
|---|---|---|
| FG000 | Galcanezumab Pre Filled Syringe (PFS) | Single dose of 240 mg galcanezumab administered subcutaneously (SC) by manual prefilled syringe. |
| FG001 | Galcanezumab Autoinjector | Single dose of 240 mg galcanezumab administered SC by autoinjector. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Galcanezumab Pre Filled Syringe (PFS) | Single dose of 240 mg galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe. |
| BG001 | Galcanezumab Autoinjector |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab | All participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (ug/mL) | 8, 24, 48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688 and 3360 hours post dose |
|
up to 8 months
All participants who received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Galcanezumab Pre Filled Syringe (PFS) | Single dose of 240 mg galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowning | General disorders | MedDRA 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | MedDRA 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | Clinicaltrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 31, 2016 | Jun 4, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 27, 2016 | Feb 27, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000628360 | galcanezumab |
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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]) |
| Pre dose, 24,48,96,120,168,264,336,504,672,1008,1244,1680,2016,2688, and 3360 hours post dose |
| Evansville |
| Indiana |
| 47710 |
| United States |
| Covance | Dallas | Texas | 75247 | United States |
| Withdrawal by Subject |
|
Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilograms (kg) |
|
|
|
| Primary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf] of Galcanezumab | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf] of Galcanezumab | All participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*ug/mL | 8, 24, 48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688 and 3360 hours post dose |
|
|
|
| Secondary | Pharmacodynamics (PD): Maximum Observed CGRP Concentration (Cmax) | Pharmacodynamics (PD): Maximum Observed CGRP Concentration (Cmax) | All participants who received at least 1 dose of study drug and had evaluable Cmax CGRP PD data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Pre dose, 24,48,96,120,168,264,336,504,672,1008,1244,1680,2016,2688, and 3360 hours post dose |
|
|
|
| Secondary | 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]) | 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]) | All participants who received at least 1 dose of study drug and had evaluable AUC[0-tlast, CGRP] PD data. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*ng/mL | Pre dose, 24,48,96,120,168,264,336,504,672,1008,1244,1680,2016,2688, and 3360 hours post dose |
|
|
|
| 1 |
| 80 |
| 1 |
| 80 |
| 27 |
| 80 |
| EG001 | Galcanezumab Autoinjector | Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector. | 0 | 80 | 1 | 80 | 38 | 80 |
| Concussion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Tinea pedis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Animal bite | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Face injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Hand fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Skull fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| White blood cells urine positive | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Neuritis | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Aggression | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
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| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Hand dermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Skin plaque | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
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