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| ID | Type | Description | Link |
|---|---|---|---|
| I4V-MC-JAGO | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to understand the relationship of 3 different dosage forms of baricitinib. This study will also explore the effect of food on how the body absorbs baricitinib. This study will last about 5 weeks, not including screening. Screening is required within 28 days prior to the date of first dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baricitinib Test Treatment 1 (T1) | Experimental | Single oral dose of 2 × 4 milligram (mg) baricitinib commercial formulation tablet fasted on Day 1 in one of five periods. |
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| Baricitinib Reference Treatment 1 (R1) | Experimental | Single oral dose of 1 × 8 mg baricitinib Phase 2 tablet fasted on Day 1 in one of five periods. |
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| Baricitinib Test Treatment 2 (T2) | Experimental | Single oral dose of 1 × 4 mg baricitinib commercial formulation tablet fasted on Day 1 in one of five periods. |
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| Baricitinib Reference Treatment 2 (R2) | Experimental | Single oral dose of 1 × 4 mg baricitinib Phase 2 tablet fasted on Day 1 in one of five periods. |
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| Baricitinib Test Treatment 2 with Meal (T2F) | Experimental | Single oral dose of 1 × 4 mg baricitinib commercial formulation tablet after food intake on Day 1 in one of five periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose | |
| PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-tlast]) of Baricitinib | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose | |
| PK: Maximum Concentration (Cmax) of Baricitinib | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hachiōji | Tokyo | 192-0071 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Baricitinib Dosing Sequence 1 | Single oral dose of study drug daily on 5 occasions: Test Treatment 1 (T1) = Baricitinib 2 × 4 milligram (mg) commercial formulation tablets in a fasted state, Reference Treatment 1 (R1) = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, Test Treatment 2 (T2) = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, Reference Treatment 2 (R2) = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, and (T2F) = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days. |
| FG001 | Baricitinib Dosing Sequence 2 | Single oral dose of study drug daily on 5 occasions: R1 = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, T1 = Baricitinib 2 × 4 mg commercial formulation tablets in a fasted state, R2 = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, T2 = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, and T2F = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days. |
| FG002 | Baricitinib Dosing Sequence 3 | Single oral dose of study drug daily on 5 occasions: T1 = Baricitinib 2 × 4 mg commercial formulation tablets in a fasted state, R1 = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, R2 = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, T2 = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, and T2F = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days. |
| FG003 | Baricitinib Dosing Sequence 4 | Single oral dose of study drug daily on 5 occasions: R1 = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, T1 = Baricitinib 2 × 4 mg commercial formulation tablets in a fasted state, T2 = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, R2 = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, and T2F = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days. |
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| Period 1 |
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| Period 5 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All randomized participants. |
| Units | Counts |
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| Participants |
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| 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 From Zero to Infinity (AUC[0-∞]) of Baricitinib | All randomized participants. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour/milliliter (ng*h/mL) | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose |
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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 T1 | Baricitinib 2 × 4 mg commercial formulation tablets administered PO QD in the fasted state on Day 1 in one of five periods. |
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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 |
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| Japan |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| 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 | No |
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| OG002 | Baricitinib T2 | Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods. |
| OG003 | Baricitinib R2 | Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods. |
| OG004 | Baricitinib T2F | Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods. |
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| Primary | PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-tlast]) of Baricitinib | All randomized participants. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose |
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| Primary | PK: Maximum Concentration (Cmax) of Baricitinib | All randomized participants. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/mL) | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose |
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| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Baricitinib R1 | Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods. | 0 | 16 | 0 | 16 |
| EG002 | Baricitinib T2 | Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods. | 0 | 16 | 0 | 16 |
| EG003 | Baricitinib R2 | Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods. | 0 | 16 | 0 | 16 |
| EG004 | Baricitinib T2F | Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods. | 0 | 16 | 0 | 16 |
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