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| ID | Type | Description | Link |
|---|---|---|---|
| I4V-MC-JAGL | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to determine the effect of baricitinib on the levels of digoxin in the blood stream and how long it takes the body to remove digoxin. This study will also look at how safe and well-tolerated baricitinib is when given at the same time as digoxin in healthy participants. This study will last approximately 3-4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baricitinib + Digoxin | Experimental | Digoxin - 0.5 milligrams (mg) administered orally, twice daily (BID), 12 hours apart on Day 1. Then, 0.25 mg administered orally, once daily (QD) on Days 2 through 16. Baricitinib - 10 mg administered orally, QD, on Days 8 through 16. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib | Drug | Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ) of Digoxin | Predose up to 24 hours post-dose on Days 7 and 16 | |
| PK: Maximum Concentration (Cmax) of Digoxin | Predose up to 24 hours post-dose on Days 7 and 16 | |
| PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin | Predose up to 24 hours post-dose on Days 7 and 16 |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Amount of Drug Excreted Unchanged During 1 Dosing Interval (Aeτ) of Digoxin | 0 to 24 hours post-dose on Days 7 and 16 | |
| PK: Renal Clearance (CLr) of Digoxin | CLr is the volume of plasma from which study drug is completely removed by the kidney in a given time and is calculated as Aeτ divided by AUCτ. |
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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 from 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 | Baricitinib + Digoxin | Digoxin - 0.5 milligrams (mg) administered orally, twice daily (BID), 12 hours apart on Day 1. Then, 0.25 mg administered orally, once daily (QD) on Days 2 through 16. Baricitinib - 10 mg administered orally, QD, immediately prior to digoxin on Days 8 through 16. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Baricitinib + Digoxin | Digoxin - 0.5 mg administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 16. Baricitinib - 10 mg administered orally, QD, immediately prior to digoxin on Days 8 through 16. |
| 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 During 1 Dosing Interval (AUCτ) of Digoxin | All enrolled participants who received study drug and had PK data to calculate AUCτ. Participants were analyzed based on the treatment they received. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter (ng*h/mL) | Predose up to 24 hours post-dose on Days 7 and 16 |
|
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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 | Digoxin Only | 0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| C000596027 | baricitinib |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| Digoxin | Drug | Administered orally |
|
| Predose to 24 hours post-dose on Days 7 and 16 |
| United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
|
|
| Primary | PK: Maximum Concentration (Cmax) of Digoxin | All enrolled participants who received study drug and had PK data to calculate Cmax. Participants were analyzed based on the treatment they received. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Predose up to 24 hours post-dose on Days 7 and 16 |
|
|
|
| Primary | PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin | All enrolled participants who received study drug and had PK data to calculate tmax. Participants were analyzed based on the treatment they received. | Posted | Median | Full Range | hours (h) | Predose up to 24 hours post-dose on Days 7 and 16 |
|
|
|
| Secondary | PK: Amount of Drug Excreted Unchanged During 1 Dosing Interval (Aeτ) of Digoxin | All enrolled participants who received study drug and had PK data to calculate Aeτ. Participants were analyzed based on the treatment they received. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams (mg) | 0 to 24 hours post-dose on Days 7 and 16 |
|
|
|
| Secondary | PK: Renal Clearance (CLr) of Digoxin | CLr is the volume of plasma from which study drug is completely removed by the kidney in a given time and is calculated as Aeτ divided by AUCτ. | All enrolled participants who received study drug and had PK data to calculate CLr. Participants were analyzed based on the treatment they received. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters/hour (L/h) | Predose to 24 hours post-dose on Days 7 and 16 |
|
|
|
| 0 |
| 28 |
| 10 |
| 28 |
| EG001 | Baricitinib + Digoxin | 10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16. | 0 | 28 | 6 | 28 |
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
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| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |