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| ID | Type | Description | Link |
|---|---|---|---|
| I6T-MC-AMBE | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to learn about the effects of LY3074828 when given as an injection just under the skin by two different devices. The study will last about 12 weeks for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 125 mg LY3074828 Prefilled Syringe (PFS) | Experimental | Reference 1: Participants received 125 mg LY3074828 solution formulation subcutaneously (SC) via 1-mL pre-filled syringe (PFS) administered in the arm. Reference 2: Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the thigh. Reference 3: Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the abdomen. |
|
| 125 mg LY3074828 Autoinjector (AI) | Experimental | Test 1: Participants received 125 mg LY3074828 solution formulation SC via 1-mL Autoinjector (AI) administered in the arm. Test 2: Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the thigh. Test 3: Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the abdomen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3074828 | Drug | Administered subcutaneously (SC) |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828 | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828 | Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85 |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Time t (AUC(0-tlast) of LY3074828, Where t is the Last Sample With a Measurable Concentration | PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC(0-tlast) of LY3074828, where t is the Last Sample with a Measurable Concentration | Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85 |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3074828 | PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3074828 | Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85 |
| Visual Analog Scale (VAS) Pain Score by Device | The pain VAS is a participant-administered single-item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (severe pain). | Day 1: 1, 5 (±1.5) and 15 (±2) minutes |
| Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location | The pain VAS is a participant-administered single-item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (severe pain). |
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Inclusion Criteria:
- Must be healthy males or females
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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test 1: 125 mg LY3074828 | Participants received 125 mg LY3074828 solution formulation subcutaneously (SC) via 1-mL Autoinjector (AI) administered in the arm. |
| FG001 | Test 2: 125 mg LY3074828 | Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the thigh. |
| FG002 | Test 3: 125 mg LY3074828 | Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the abdomen. |
| FG003 | Reference 1: 125 mg LY3074828 | Participants received 125 mg LY3074828 solution formulation SC via 1-mL pre-filled syringe (PFS) administered in the arm. |
| FG004 | Reference 2: 125 mg LY3074828 | Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the thigh. |
| FG005 | Reference 3: 125 mg LY3074828 | Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the abdomen. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test 1: 125 mg LY3074828 | Participants received 125 mg LY3074828 solution formulation subcutaneously (SC) via 1-mL Autoinjector (AI) administered in the arm. |
| BG001 | Test 2: 125 mg LY3074828 |
| Units | Counts |
|---|---|
| Participants |
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| 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 Observed Drug Concentration (Cmax) of LY3074828 | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828 | All participants who received at least one dose of study drug and had evaluable PK data. Per protocol, PK analysis were performed to evaluate solution formulation using a 1-mL PFS and a 1-mL AI. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | microgram/milliliter (ug/mL) | Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85 |
|
Up To 85 Days
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 | Test 1: 125 mg LY3074828 | Participants received 125 mg LY3074828 solution formulation subcutaneously (SC) via 1-mL Autoinjector (AI) administered in the arm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA 21.1 | 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 | Dec 17, 2018 | Feb 26, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 4, 2019 | Feb 22, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000708407 | mirikizumab |
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| Pre-filled syringe (PFS) | Device | PFS used to administer LY3074828 |
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| Autoinjector (AI) | Device | AI used to administer LY3074828 |
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| Day 1: 1, 5 (±1.5) and 15 (±2) minutes |
Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the thigh.
| BG002 | Test 3: 125 mg LY3074828 | Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the abdomen. |
| BG003 | Reference 1: 125 mg LY3074828 | Participants received 125 mg LY3074828 solution formulation SC via 1-mL pre-filled syringe (PFS) administered in the arm. |
| BG004 | Reference 2: 125 mg LY3074828 | Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the thigh. |
| BG005 | Reference 3: 125 mg LY3074828 | Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the abdomen. |
| BG006 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the arm, thigh or abdomen. |
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Time t (AUC(0-tlast) of LY3074828, Where t is the Last Sample With a Measurable Concentration | PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC(0-tlast) of LY3074828, where t is the Last Sample with a Measurable Concentration | All participants who received at least one dose of study drug and had evaluable PK data. Per protocol, PK analysis were performed to evaluate solution formulation using a 1-mL PFS and a 1-mL AI. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | microgram*day/milliliter (ug*day/mL) | Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85 |
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|
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| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3074828 | PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3074828 | All participants who received at least one dose of study drug and had evaluable PK data. Per protocol, PK analysis were performed to evaluate formulation using a 1-mL PFS and a 1-mL AI. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | ug*day/mL | Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85 |
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| Primary | Visual Analog Scale (VAS) Pain Score by Device | The pain VAS is a participant-administered single-item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (severe pain). | All participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | millimeter (mm) | Day 1: 1, 5 (±1.5) and 15 (±2) minutes |
|
|
|
| Primary | Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location | The pain VAS is a participant-administered single-item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (severe pain). | All participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | millimeter (mm) | Day 1: 1, 5 (±1.5) and 15 (±2) minutes |
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|
| 0 |
| 11 |
| 0 |
| 11 |
| 3 |
| 11 |
| EG001 | Test 2: 125 mg LY3074828 | Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the thigh. | 0 | 11 | 0 | 11 | 2 | 11 |
| EG002 | Test 3: 125 mg LY3074828 | Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the abdomen. | 0 | 11 | 0 | 11 | 2 | 11 |
| EG003 | Reference 1: 125 mg LY3074828 | Participants received 125 mg LY3074828 solution formulation SC via 1-mL pre-filled syringe (PFS) administered in the arm. | 0 | 11 | 0 | 11 | 1 | 11 |
| EG004 | Reference 2: 125 mg LY3074828 | Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the thigh. | 0 | 11 | 0 | 11 | 2 | 11 |
| EG005 | Reference 3: 125 mg LY3074828 | Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the abdomen. | 0 | 11 | 0 | 11 | 7 | 11 |
| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Laboratory test abnormal | Investigations | MedDRA 21.1 | Systematic Assessment |
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| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| 15 Minute (±2) |
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| 5 Minutes (±1.5) |
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| 15 Minutes (±2) |
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