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| ID | Type | Description | Link |
|---|---|---|---|
| I6T-MC-AMAE | 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 total duration of the clinical trial will be approximately 13 weeks, not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference: 250 mg LY3074828 | Experimental | 250 mg LY3074828 lyophilized formulation administered subcutaneously (SC) as 3 injections |
|
| Test 1: 250 mg LY3074828 | Experimental | 250 mg LY3074828 solution formulation administered as SC injections in two prefilled syringes |
|
| Test 2: 500 mg LY3074828 | Experimental | 500 mg LY3074828 solution formulation administered as SC injections in four prefilled syringes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3074828 | Biological | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (DN-AUC[0-tlast]) of LY3074828 | PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (DN-AUC[0-tlast]) of LY3074828 was evaluated. Unit of measure expansion: microgram*day per milliliter per milligram (µg*day/mL/mg). | Predose; 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680 and 2016 hours postdose |
| PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (DN-AUC[0-∞]) of LY3074828 | PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (DN-AUC[0-∞]) of LY3074828 was evaluated. | Predose; 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680 and 2016 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) | Number of participants with positive treatment emergent anti-drug antibodies was summarized by treatment group. A treatment-emergent ADA (TEADA) was defined as: having a negative ADA at baseline and an ADA titer greater than or equal to 1:20 (that is (i.e.), greater than 2-fold from the minimal required dilution of 1:10) any time post baseline (i.e., treatment-induced); or a 4-fold or greater change in ADA titer from baseline for participants that had a detectable ADA titer at baseline (i.e., treatment boosted). |
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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 | Dallas | Texas | 75247 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reference: 250 mg LY3074828 | Participants received 250 mg LY3074828 lyophilized formulation, as 3 subcutaneous (SC) injections. |
| FG001 | Test 1: 250 mg LY3074828 | Participants received 250 mg LY3074828 solution formulation in 2 prefilled syringes (PFSs), as SC injections. |
| FG002 | Test 2: 500 mg LY3074828 | Participants received 500 mg LY3074828 solution formulation in 4 PFSs, as SC injections. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Reference: 250 mg LY3074828 | Participants received 250 mg LY3074828 lyophilized formulation, as 3 SC injections |
| BG001 | Test 1: 250 mg LY3074828 | Participants received 250 mg LY3074828 solution formulation in 2 PFSs, as SC injections |
| 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): Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (DN-AUC[0-tlast]) of LY3074828 | PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (DN-AUC[0-tlast]) of LY3074828 was evaluated. Unit of measure expansion: microgram*day per milliliter per milligram (µg*day/mL/mg). | All enrolled participants who received at least one dose of LY3074828 and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg*day/mL/mg | Predose; 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680 and 2016 hours postdose |
|
Up to 85 days after administration of study drug
All enrolled 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 | Reference: 250 mg LY3074828 | Participants received 250 mg LY3074828 lyophilized formulation, as 3 SC injections. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | 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 | Apr 5, 2017 | Oct 12, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 8, 2017 | Oct 12, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000708407 | mirikizumab |
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| Predose Day 1 Through Day 85 |
| BG002 | Test 2: 500 mg LY3074828 | Participants received 500 mg LY3074828 solution formulation in 4 PFSs, as SC injections |
| BG003 | 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 |
|
| OG001 |
| Test 1: 250 mg LY3074828 |
Participants received 250 mg LY3074828 solution formulation in 2 PFSs, as SC injections. |
| OG002 | Test 2: 500 mg LY3074828 | Participants received 500 mg LY3074828 solution formulation in 4 PFSs, as SC injections. |
|
|
|
| Primary | PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (DN-AUC[0-∞]) of LY3074828 | PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (DN-AUC[0-∞]) of LY3074828 was evaluated. | All enrolled participants who received at least one dose of LY3074828 and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg.day/mL/mg | Predose; 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680 and 2016 hours postdose |
|
|
|
|
| Secondary | Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) | Number of participants with positive treatment emergent anti-drug antibodies was summarized by treatment group. A treatment-emergent ADA (TEADA) was defined as: having a negative ADA at baseline and an ADA titer greater than or equal to 1:20 (that is (i.e.), greater than 2-fold from the minimal required dilution of 1:10) any time post baseline (i.e., treatment-induced); or a 4-fold or greater change in ADA titer from baseline for participants that had a detectable ADA titer at baseline (i.e., treatment boosted). | All randomized participants who received at least one dose of LY3074828 and had evaluable anti-drug antibody measurement. | Posted | Count of Participants | Participants | No | Predose Day 1 Through Day 85 |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 16 |
| 18 |
| EG001 | Test 1: 250 mg LY3074828 | Participants received 250 mg LY3074828 solution formulation in 2 PFSs, as SC injections. | 0 | 18 | 0 | 18 | 15 | 18 |
| EG002 | Test 2: 500 mg LY3074828 | Participants received 500 mg LY3074828 solution formulation in 4 PFSs, as SC injections. | 0 | 18 | 0 | 18 | 18 | 18 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Ratio of geometric least squares means |
| 1.00 |
| 2-Sided |
| 90 |
| 0.833 |
| 1.21 |
| Other |
| Ratio of geometric least squares means | 0.982 | 2-Sided | 90 | 0.817 | 1.18 | Other |