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| ID | Type | Description | Link |
|---|---|---|---|
| I6T-MC-AMAL | Other Identifier | Eli Lilly and Company | |
| 2016-003584-18 | EudraCT Number |
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This study is conducted to compare how much mirikizumab, in two different formulations, is absorbed into the bloodstream and how long the body takes to get rid of it, when given as an injection under the skin or into the veins. Side effects of the injection will be collected. Each participant will be in the study for about 18 weeks, including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirikizumab Test Subcutaneous (SC) 1 | Experimental | 250 mg mirikizumab test formulation given as a single injection SC in healthy participants |
|
| Mirikizumab Test SC 2 | Experimental | 250 mg mirikizumab test formulation given as two injections given SC in healthy participants |
|
| Mirikizumab Test Intravenous (IV) | Experimental | 250 mg mirikizumab test formulation given as an infusion into the vein in healthy participants |
|
| Mirikizumab Reference | Active Comparator | 250 mg mirikizumab reference formulation given as three injections subcutaneous (SC) in healthy participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirikizumab Test | Biological | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC[0-∞]) of Mirikizumab | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC[0-∞]) of Mirikizumab | 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Maximum Observed Concentration (Cmax) of Mirikizumab | PK: Maximum Observed Concentration (Cmax) of Mirikizumab | 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose |
| PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab |
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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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Leeds | West Yorkshire | LS2 9LH |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mirikizumab Reference | 250 mg mirikizumab reference formulation given as three injections subcutaneous (SC) in healthy participants. |
| FG001 | Mirikizumab Test SC 2 | 250 mg mirikizumab test formulation given as two injections given SC in healthy participants |
| FG002 | Mirikizumab Test SC 1 | 250 mg mirikizumab test formulation given as a single injection SC in healthy participants |
| FG003 | Mirikizumab Test Intravenous (IV) | 250 mg mirikizumab test formulation given as an infusion into the vein in healthy participants |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mirikizumab Reference | 250 mg mirikizumab reference formulation given as three injections subcutaneous (SC) in healthy participants. |
| BG001 | Mirikizumab Test SC 2 | 250 mg mirikizumab test formulation given as two injections given SC in healthy participants |
| 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): Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC[0-∞]) of Mirikizumab | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC[0-∞]) of Mirikizumab | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram* Day/Milliliter(µg*day/mL) | 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose |
|
Up To 4 Months
All participants who received at least one 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 | Mirikizumab Reference | 250 mg mirikizumab reference formulation given as three injections subcutaneous (SC) in healthy participants. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 19.1 | 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 | Jan 20, 2017 | Oct 31, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 28, 2017 | Oct 31, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000708407 | mirikizumab |
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| Mirikizumab Test | Biological | Administered IV |
|
|
| Mirikizumab Reference | Biological | Administered SC |
|
|
PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab |
| 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose |
| United Kingdom |
| BG002 | Mirikizumab Test SC 1 | 250 mg mirikizumab test formulation given as a single injection SC in healthy participants |
| BG003 | Mirikizumab Test Intravenous (IV) | 250 mg mirikizumab test formulation given as an infusion into the vein in healthy participants |
| BG004 | 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 | No |
|
250 mg mirikizumab test formulation given as two injections given SC in healthy participants |
| OG002 | Mirikizumab Test SC 1 | 250 mg mirikizumab test formulation given as a single injection SC in healthy participants |
| OG003 | Mirikizumab Test Intravenous (IV) | 250 mg mirikizumab test formulation given as an infusion into the vein in healthy participants |
|
|
|
| Secondary | PK: Maximum Observed Concentration (Cmax) of Mirikizumab | PK: Maximum Observed Concentration (Cmax) of Mirikizumab | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram/Milliliter (µg/mL) | 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose |
|
|
|
|
| Secondary | PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab | PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Median | Full Range | Hour (h) | 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose |
|
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 17 |
| 17 |
| EG001 | Mirikizumab Test SC 2 | 250 mg mirikizumab test formulation given as two injections given SC in healthy participants | 0 | 16 | 0 | 16 | 15 | 16 |
| EG002 | Mirikizumab Test SC 1 | 250 mg mirikizumab test formulation given as a single injection SC in healthy participants | 0 | 17 | 0 | 17 | 17 | 17 |
| EG003 | Mirikizumab Test Intravenous (IV) | 250 mg mirikizumab test formulation given as an infusion into the vein in healthy participants | 0 | 17 | 0 | 17 | 15 | 17 |
| Ear pain | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Lip dry | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Injection site mass | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
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| Bladder irritation | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
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| Ratio of Geometric Least Squares Means |
| 0.753 |
| 2-Sided |
| 90 |
| 0.619 |
| 0.916 |
| Other |
| Median Difference (Final Values) |
| 0.25 |
| 2-Sided |
| 90 |
| -0.25 |
| 23.97 |
In this outcome, the median difference is not calculated by subtracting two observations, it is derived by "Hodges-Lehmann approach to estimating location shift". This method will give the value of 0.25. |
| Other |