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| ID | Type | Description | Link |
|---|---|---|---|
| I5Q-MC-CGAO | Other Identifier | Eli Lilly and Company |
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The purposes of this study are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galcanezumab Solution Formulation-Part A | Experimental | Galcanezumab solution formulation in a prefilled syringe given SC once. |
|
| Placebo-Part A | Placebo Comparator | Placebo in a prefilled syringe given SC once. |
|
| Galcanezumab Lyophilized Formulation-Part B | Experimental | Galcanezumab lyophilized (freeze dried) formulation given SC once. |
|
| Galcanezumab Solution Formulation-Part B | Experimental | Galcanezumab solution formulation in a prefilled syringe given SC once. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galcanezumab | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (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 |
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Inclusion Criteria:
Exclusion Criteria:
- Currently smoke in excess of 5 cigarettes/day
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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 | Dallas | Texas | 75247 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31482569 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 240 mg Galcanezumab Solution - Part A | Participants received 240 milligram (mg) Galcanezumab as a solution formulation by subcutaneous injection. |
| FG001 | Placebo - Part A | Participants received placebo by subcutaneous injection. |
| FG002 | 300 mg Galcanezumab Lyophilized - Part B | Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection. |
| FG003 | 300 mg Galcanezumab Solution - Part B | Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 240 mg Galcanezumab Solution - Part A | Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection. |
| BG001 | Placebo - Part A | Participants received placebo by subcutaneous injection. |
| 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 | 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. | All randomized participants who received at least one dose of study drug in Part A and had at least one post dose safety assessment. | Posted | Count of Participants | Participants | No | Part A: Predose through 48 hours post dose |
|
Up to 20 Weeks
All randomized participants.
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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 240 mg - Part A | Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 18.0 | 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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| ID | Term |
|---|---|
| C000628360 | galcanezumab |
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|
| Placebo | Drug | Administered SC |
|
| 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): 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: 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: 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: 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): Maximum Concentration (Cmax) of Plasma 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 |
| Withdrawal by Subject |
|
| Protocol Violation |
|
| BG002 | 300 mg Galcanezumab Lyophilized - Part B | Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection. |
| BG003 | 300 mg Galcanezumab Solution - Part B | Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Basal Metabolic Index (BMI) | Mean | Standard Deviation | Kilogram per square meter |
|
Participants received placebo by subcutaneous injection. |
|
|
| Primary | 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. | All randomized participants who received at least one dose of study drug in Part B and had evaluable AUC zero to infinity PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*microgram per milliliter(day*μg/mL) | Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose |
|
|
|
| Primary | Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab | Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab. | All randomized participants who received at least one dose of study drug in part B and had evaluable Cmax PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter (μg/mL) | Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose |
|
|
|
| Secondary | Part A: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP) | Part A: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP). | All randomized participants who received at least one dose of study drug and had evaluable plasma Tmax CGRP data in Part A. | Posted | Median | Full Range | Days | Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose |
|
|
|
| Secondary | 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): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC [0 to Tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP). | All randomized participants who received at least one dose of study drug and had evaluable plasma AUC CGRP data in Part A. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*ng/mL | Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose |
|
|
|
| Secondary | Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP | Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP. | All randomized participants who received at least one dose of study drug and had evaluable plasma Cmax CGRP data in Part A. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose |
|
|
|
| Secondary | Part B: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP) | Part B: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP). | All randomized participants who received at least one dose of study drug and had evaluable plasma Tmax CGRP data in Part B. | Posted | Median | Full Range | Days | Part B: Predose, 8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose |
|
|
|
| Secondary | 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: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve from time zero to tlast (AUC[0-tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP). | All randomized participants who received at least one dose of study drug and had evaluable plasma AUC zero to tlast CGRP data in Part B. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*ng/mL | Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose |
|
|
|
| Secondary | Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP | Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP. | All randomized participants who received at least one dose of study drug and had evaluable plasma Cmax CGRP data in Part B. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 7 |
| 15 |
| EG001 | Placebo - Part A | Participants received placebo by subcutaneous injection. | 0 | 3 | 1 | 3 | 1 | 3 |
| EG002 | Galcanezumab 300 mg Lyophilized - Part B | Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection. | 0 | 80 | 1 | 80 | 25 | 80 |
| EG003 | Galcanezumab 300 mg Solution - Part B | Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection. | 0 | 80 | 0 | 80 | 20 | 80 |
| Cellulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dental discomfort | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Facial pain | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Vessel puncture site reaction | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Biopsy breast | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Physical breast examination abnormal | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Laryngeal cyst | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
Not provided