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| ID | Type | Description | Link |
|---|---|---|---|
| I4V-MC-JAGK | Other Identifier | Eli Lilly and Company |
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The purposes of this study are to look at what effect multiple doses of rifampicin have on a single dose of baricitinib and to look at the safety and tolerability of these drugs. Side effects will be documented. The study will last approximately 31 days from the first dose to the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baricitinib | Experimental | Single oral dose of 10 milligrams (mg) baricitinib on Day 1. |
|
| Baricitinib + Rifampicin | Experimental | Oral doses of 600 mg rifampicin once daily on Days 3 to 11, with a single oral dose of 10 mg baricitinib co-administered on Day 10. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK: Maximum Concentration (Cmax) of Baricitinib | Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose | |
| PK: Area Under the Concentration Versus Time Curve From 0 to Infinity [AUC(0-∞)] of Baricitinib | Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose | |
| PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib | Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 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, fixed-sequence, 2-period study conducted in healthy participants to compare the single dose pharmacokinetics (PK) of baricitinib when given alone and when coadministered with rifampicin.
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| ID | Title | Description |
|---|---|---|
| FG000 | Baricitinib Then Baricitinib and Rifampicin | Period 1: 10-milligram (mg) dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1. Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally once daily (QD) on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Days 1-2) |
| ||||||||||||||||
| Period 2 (Days 3-32) |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Baricitinib Then Baricitinib and Rifampicin | Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1. Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10. |
| 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 | PK: Maximum Concentration (Cmax) of Baricitinib | Participants who received study drug (baricitinib in Period 1 and at least 1 dose of rifampicin and baricitinib in Period 2) and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose |
|
Baseline through study completion (up to Day 32)
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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 | A 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1. Adverse events (AEs) are reported from baseline through predose on Day 3. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | 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 |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Rifampicin | 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 |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve From 0 to Infinity [AUC(0-∞)] of Baricitinib | Participants who received study drug (baricitinib in Period 1 and at least 1 dose of rifampicin and baricitinib in Period 2) and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter (ng*h/mL) | Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose |
|
|
|
| Primary | PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib | Participants who received study drug (baricitinib in Period 1 and at least 1 dose of rifampicin and baricitinib in Period 2) and who had evaluable PK data. | Posted | Median | Full Range | hours (h) | Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose |
|
|
|
| 0 |
| 18 |
| 3 |
| 18 |
| EG001 | Rifampicin | A 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 9. AEs are reported postdose on Day 3 through predose on Day 10. | 0 | 18 | 3 | 18 |
| EG002 | Baricitinib and Rifampicin | A 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 10 and 11, with coadministration of a 10-mg dose of baricitinib on Day 10. AEs are reported postdose on Day 10 up to Day 32. | 0 | 18 | 5 | 18 |
| Flatulence | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Gingival bleeding | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Thirst | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Mood swings | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Terminal insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
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| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |