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| ID | Type | Description | Link |
|---|---|---|---|
| I8D-MC-AZEP | Other Identifier | Eli Lilly and Company. | |
| 2017-001181-18 | EudraCT Number |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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The purpose of this study is to measure how much LY3314814 gets into the bloodstream when it is given as a single dose by mouth and as an intravenous (IV) infusion over two hours. The study will last at least two weeks for each participant, not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3314814 | Experimental | Single 50 milligram (mg) dose of LY3314814 administered orally |
|
| [13C415N3] LY3314814 | Experimental | Single 100 micrograms (μg) intravenous (IV) dose of [13C415N3] LY3314814 administered as an IV infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3314814 | Drug | Administered orally |
| |
| [13C415N3] LY3314814 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Bioavailability of LY3314814 | Absolute bioavailability was quantified using a mixed-effects analysis of variance (ANOVA) model applied to the log-transformed dose-normalized AUC(0-∞) of LY3314814 oral dosing and IV administered [13C415N3]-LY3314814. | Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814 | Pharmacokinetics: Area Under the Drug Concentration-Time Curve from Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814 | Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose |
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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 |
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| Label | URL |
|---|---|
| CSP | View source |
| SAP | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY3314814 + [13C415N3] LY3314814 | Single 50 milligram (mg) dose of LY3314814 administered orally simultaneously with a single 100 microgram (μg) intravenous (IV) infusion of [13C415N3] LY3314814 over 2 hours on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who received at least one dose of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | LY3314814 + [13C415N3] LY3314814 | Single 50 milligram (mg) dose of LY3314814 administered orally simultaneously with a single 100 microgram (μg) intravenous (IV) infusion of [13C415N3] LY3314814 over 2 hours on Day 1. |
| 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 | Absolute Bioavailability of LY3314814 | Absolute bioavailability was quantified using a mixed-effects analysis of variance (ANOVA) model applied to the log-transformed dose-normalized AUC(0-∞) of LY3314814 oral dosing and IV administered [13C415N3]-LY3314814. | All participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter per mg | Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose |
|
From baseline to end of study (Up To 7 days)
All participants who have 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 | LY3314814 + [13C415N3] LY3314814 | Single 50 milligram (mg) dose of LY3314814 administered orally simultaneously with a single 100 microgram (μg) intravenous (IV) infusion of [13C415N3] LY3314814 over 2 hours on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 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 | Oct 13, 2017 | Nov 29, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 9, 2018 | Nov 29, 2018 | SAP_001.pdf |
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Open label
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| Drug |
Administered as an IV infusion |
|
| United Kingdom |
| CSP | View source |
| SAP | View source |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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Single 100 μg IV dose of [13C415N3] LY3314814 administered as an IV infusion.
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|
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| Secondary | Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814 | Pharmacokinetics: Area Under the Drug Concentration-Time Curve from Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814 | All participants who received one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose |
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| 0 |
| 8 |
| 0 |
| 8 |
| 3 |
| 8 |
| Oral herpes | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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