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| ID | Type | Description | Link |
|---|---|---|---|
| I6T-MC-AMAR | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to look at the amount of the study drug, LY3074828, that gets into the blood stream and how long it takes the body to get rid of LY3074828 when given as different formulations. The tolerability of LY3074828 will also be evaluated and information about any side effects experienced will be collected.
Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 12 weeks, not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 1: 250 mg LY3074828 | Experimental | Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-milligram/milliliter [mg/mL]) administered subcutaneously (SC) via an auto-injector (AI) in arm. |
|
| Test 2: 250 mg LY3074828 | Experimental | Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in thigh. |
|
| Test 3: 250 mg LY3074828 | Experimental | Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in abdomen. |
|
| Reference 1: 250 mg LY3074828 | Experimental | Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm. The second injection was administered 20 (±2) minutes after the first injection. |
|
| Reference 2: 250 mg LY3074828 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3074828 | Biological | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3074828 by Device | Pharmacokinetics: Cmax of LY3074828 | Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828 by Device | Pharmacokinetics: Area Under the Concentration versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828 | Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose |
| Visual Analogue Scale (VAS) Pain Assessment by Device | The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain. | Day 1: 1, 5 (±1.5) and 15 (±2) minutes |
| Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain. | Day 1: 1, 5 (±1.5) and 15 (±2) minutes |
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Inclusion Criteria: Healthy participants.
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: 250 mg LY3074828 | Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-milligram/milliliter [mg/mL]) administered subcutaneously(SC) via an auto-injector (AI) in arm. |
| FG001 | Test 2: 250 mg LY3074828 | Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in thigh. |
| FG002 | Test 3: 250 mg LY3074828 | Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in abdomen. |
| FG003 | Reference 1: 250 mg LY3074828 | Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm.The second injection was administered 20 (±2) minutes after the first injection. |
| FG004 | Reference 2: 250 mg LY3074828 | Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh. The second injection was administered 20 (±2) minutes after the first injection. |
| FG005 | Reference 3: 250 mg LY3074828 | Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen.The second injection was administered 20 (±2) minutes after the first injection. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test 1: 250 mg LY3074828 | Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an auto-injector (AI) in arm. |
| BG001 | Test 2: 250 mg LY3074828 |
| 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: Maximum Concentration (Cmax) of LY3074828 by Device | Pharmacokinetics: Cmax of LY3074828 | All participants who received at least one dose of study drug. Per protocol, PK analysis were performed to compare all PFS participants together versus all AI participants together. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (μg/mL) | Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose |
|
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: 250 mg LY3074828 | Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an auto-injector (AI) in arm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA 21.0 | 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 | Sep 13, 2018 | Mar 4, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 25, 2018 | Mar 4, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000708407 | mirikizumab |
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Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh.
The second injection was administered 20 (±2) minutes after the first injection.
|
| Reference 3: 250 mg LY3074828 | Experimental | Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen. The second injection was administered 20 (±2) minutes after the first injection. |
|
| LY3074828 | Drug | Administered SC |
|
| Auto-injector (AI) | Device | AI to administer LY3074828 |
|
| Prefilled syringe (PFS) | Device | PFS to administer LY3074828 |
|
Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in thigh.
| BG002 | Test 3: 250 mg LY3074828 | Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in abdomen. |
| BG003 | Reference 1: 250 mg LY3074828 | Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm.The second injection was administered 20 (±2) minutes after the first injection. |
| BG004 | Reference 2: 250 mg LY3074828 | Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh.The second injection was administered 20 (±2) minutes after the first injection. |
| BG005 | Reference 3: 250 mg LY3074828 | Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen.The second injection was administered 20 (±2) minutes after the first injection. |
| BG006 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
|
| 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 |
|
| OG001 | 250 mg LY3074828 PFS | Reference 1: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm. Reference 2: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh. Reference 3: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen. The second injection was administered 20 (±2) minutes after the first injection. |
|
|
| Primary | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828 by Device | Pharmacokinetics: 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. Per protocol, PK analysis were performed to compare all PFS participants together versus all AI participants together. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*day per millileter (μg*day/mL) | Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose |
|
|
|
| Primary | Visual Analogue Scale (VAS) Pain Assessment by Device | The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain. | All participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | millimeter | Day 1: 1, 5 (±1.5) and 15 (±2) minutes |
|
|
|
| Primary | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain. | All participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | millimeter | Day 1: 1, 5 (±1.5) and 15 (±2) minutes |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 3 |
| 11 |
| EG001 | Test 2: 250 mg LY3074828 | Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in thigh. | 0 | 11 | 0 | 11 | 6 | 11 |
| EG002 | Test 3: 250 mg LY3074828 | Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in abdomen. | 0 | 11 | 0 | 11 | 2 | 11 |
| EG003 | Reference 1: 250 mg LY3074828 | Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm.The second injection was administered 20 (±2) minutes after the first injection. | 0 | 11 | 0 | 11 | 3 | 11 |
| EG004 | Reference 2: 250 mg LY3074828 | Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh.The second injection was administered 20 (±2) minutes after the first injection. | 0 | 11 | 0 | 11 | 6 | 11 |
| EG005 | Reference 3: 250 mg LY3074828 | Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen.The second injection was administered 20 (±2) minutes after the first injection. | 0 | 11 | 0 | 11 | 4 | 11 |
| Refraction disorder | Eye disorders | MedDRA 21.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| Stress fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 21.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
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| 15 min (±2) |
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| Arm: 5 min (±1.5) |
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| Arm: 15 min (±2) |
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| Thigh: 1 min |
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| Thigh: 5 min (±1.5) |
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| Thigh:15 min (±2) |
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| Abdomen: 1 min |
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| Abdomen: 5 min (±1.5) |
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| Abdomen: 15 min (±2) |
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