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| ID | Type | Description | Link |
|---|---|---|---|
| I4V-MC-JAGJ | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to look at the effect of ketoconazole and fluconazole on how much baricitinib gets into the blood stream. The study will also look at the tolerability of baricitinib and ketoconazole when given together and the tolerability of baricitinib and fluconazole when given together.
Participants will be recruited into 1 of 2 treatment groups (Group A or Group B). Each treatment group will participate in 2 study periods. Participants will take baricitinib alone in 1 period and baricitinib with either ketoconazole or fluconazole in the other period. This study will last approximately 7 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baricitinib + Ketoconazole | Experimental | Baricitinib - 10 milligrams (mg) administered orally once on Day 1 of Period 1 and on Day 6 of Period 2. Ketoconazole - 400 mg administered orally once daily (QD) for 6 days (Day 3 through Day 8) in Period 2. |
|
| Baricitinib + Fluconazole | Experimental | Baricitinib - 10 mg administered orally once on Day 1 of Period 1 and on Day 7 of Period 2. Fluconazole - 400 mg administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole | Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose | |
| PK: AUC(0-∞) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole | Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose | |
| PK: Maximum Concentration (Cmax) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole | Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose | |
| PK: Cmax of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole | Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose | |
| PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole | Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose | |
| PK: Tmax of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole | Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 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, 2-period, fixed-sequence study. Period 1 was from Day 1 through Day 2. Period 2 was from Day 3 through Day 9 for baricitinib + ketoconazole (Group A) and Day 3 through Day 10 for baricitinib + fluconazole (Group B).
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| ID | Title | Description |
|---|---|---|
| FG000 | Baricitinib + Ketoconazole (Group A) | 10 milligrams (mg) baricitinib administered orally once on Day 1 of Period 1 and on Day 6 of Period 2. 400 mg ketoconazole administered orally once daily (QD) for 6 days (Day 3 through Day 8) in Period 2. |
| FG001 | Baricitinib + Fluconazole (Group B) | 10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 7 of Period 2. 400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Baricitinib + Ketoconazole (Group A) | 10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 6 of Period 2. 400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2. |
| BG001 | Baricitinib + Fluconazole (Group B) |
| 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 Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole | All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ketoconazole 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 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose |
|
Baseline through study completion (up to Day 23).
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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 (Group A) | 10 mg baricitinib administered orally once on Day 1 of 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 |
|---|---|---|---|---|---|
| Vision blurred | 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 |
| D007654 | Ketoconazole |
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014230 | Triazoles |
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| Ketoconazole | Drug | Administered orally |
|
| Fluconazole | Drug | Administered orally |
|
| United Kingdom |
| Received Baricitinib |
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| COMPLETED |
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| NOT COMPLETED |
|
|
10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 7 of Period 2. 400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | No |
|
10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.
|
|
| Primary | PK: AUC(0-∞) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole | All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + fluconazole in Period 2) and had PK data to calculate AUC(0-∞) of baricitinib. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose |
|
|
|
| Primary | PK: Maximum Concentration (Cmax) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole | All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ketoconazole 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 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose |
|
|
|
| Primary | PK: Cmax of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole | All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + fluconazole in Period 2) and had PK data to calculate Cmax of baricitinib. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose |
|
|
|
| Primary | PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole | All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ketoconazole in Period 2) and had PK data to calculate Tmax of baricitinib. | Posted | Median | Full Range | hours | Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose |
|
|
|
| Primary | PK: Tmax of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole | All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + fluconazole in Period 2) and had PK data to calculate Tmax of baricitinib. | Posted | Median | Full Range | hours | Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose |
|
|
|
| 0 |
| 18 |
| 4 |
| 18 |
| EG001 | Ketoconazole (Group A) | 400 mg ketoconazole administered orally QD on Day 3 through Day 5 in Period 2. Adverse events are reported from postdose on Day 3 through predose on Day 6. | 0 | 18 | 7 | 18 |
| EG002 | Baricitinib + Ketoconazole (Group A) | 10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg ketoconazole administered orally QD on Day 6 through Day 8 in Period 2. Adverse events are reported from postdose on Day 6 up to Day 22. | 0 | 17 | 4 | 17 |
| EG003 | Baricitinib (Group B) | 10 mg baricitinib administered orally once on Day 1 of Period 1. Adverse events are reported from baseline through predose on Day 3. | 0 | 18 | 3 | 18 |
| EG004 | Fluconazole (Group B) | 400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD on Day 4 through Day 6 in Period 2. Adverse events are reported from postdose on Day 3 through predose on Day 7. | 0 | 18 | 4 | 18 |
| EG005 | Baricitinib + Fluconazole (Group B) | 10 mg baricitinib administered orally once on Day 7 of Period 2. 200 mg fluconazole administered orally QD on Day 7 through Day 9 in Period 2. Adverse events are reported from postdose on Day 7 up to Day 23. | 0 | 17 | 6 | 17 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Anorectal discomfort | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Retching | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Catheter site related reaction | 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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| Tooth injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neck pain | 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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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
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| D001393 |
| Azoles |