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| ID | Type | Description | Link |
|---|---|---|---|
| I4V-MC-JAGG | Other Identifier | Eli Lilly and Company |
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The purposes of this study are to assess how the body handles baricitinib when it is given with another drug called probenecid. The study doctor will measure the amount of baricitinib that is absorbed into the blood stream and the time that it takes to remove baricitinib from the body. The safety and tolerability of these drugs will be studied. The study will last about 18 days from the first dose to the end of the study (not including screening).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baricitinib | Experimental | Single oral dose of 4 milligrams (mg) baricitinib on Day 1 |
|
| Baricitinib + Probenecid | Experimental | Oral doses of 1000 mg probenecid once daily on Days 3 through 7, with a single oral dose of 4 mg baricitinib co-administered on Day 5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib | Drug | Administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib | Days 1 and 5: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 (Day 5 dosing only) hours postdose | |
| PK: Area Under the Concentration Curve From Time 0 to Infinity [AUC (0-∞)] of Baricitinib | Days 1 and 5: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 (Day 5 dosing only) hours postdose |
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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 |
This was an open-label, 2-period, fixed-sequence study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Baricitinib | 4 milligram (mg) baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 5 in Period 2. 1000 mg probenecid tablet administered orally, twice daily (BID), on Days 3 through 7 in Period 2. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Day 1 Through Predose Day 3) |
| ||||||||||||||||
| Period 2 (At Dosing Day 3 Through Day 8) |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Baricitinib | 4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 5 in Period 2. 1000 mg probenecid tablet administered orally, BID, on Days 3 through 7 in Period 2. |
| 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): Maximum Concentration (Cmax) of Baricitinib | All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + probenecid in Period 2) and had PK data to calculate Cmax of baricitinib. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Days 1 and 5: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 (Day 5 dosing only) hours postdose |
|
Baseline through study completion (up to Day 18).
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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 | Baricitinib | 4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1. Adverse events are reported from baseline through predose on Day 3. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular hyperaemia | Eye 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 |
| D011339 | Probenecid |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Probenecid |
| Drug |
Administered orally |
|
| United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | No |
|
|
|
| Primary | PK: Area Under the Concentration Curve From Time 0 to Infinity [AUC (0-∞)] of Baricitinib | All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + probenecid in Period 2) and had PK data to calculate AUC (0-∞) of baricitinib. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter (ng*h/mL) | Days 1 and 5: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 (Day 5 dosing only) hours postdose |
|
|
|
| 0 |
| 18 |
| 3 |
| 18 |
| EG001 | Probenecid | 1000 mg probenecid tablet administered orally, BID, on Days 3 through 4 in Period 2. Adverse events are reported from postdose on Day 3 through predose on Day 5. | 0 | 18 | 3 | 18 |
| EG002 | Baricitinib + Probenecid | 4 mg baricitinib tablet administered orally, once, on Day 5 in Period 2. 1000 mg probenecid tablet administered orally, BID, on Days 5 through 7 in Period 2. Adverse events are reported from postdose on Day 5 up to Day 18. | 0 | 18 | 8 | 18 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Urine odour abnormal | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
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| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
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| Sulfur Compounds |