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| ID | Type | Description | Link |
|---|---|---|---|
| I4V-GH-JAGR | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to investigate the safety and tolerability of the study drug known as baricitinib in healthy Chinese participants. The study will measure how the body absorbs, breaks down and gets rid of baricitinib. The study will last about 20 days, not including screening. This study is for research purposes only, and is not intended to treat any medical condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 milligram (mg) Baricitinib | Experimental | 2mg Baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days). |
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| 4mg Baricitinib | Experimental | 4mg Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days). |
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| 10mg Baricitinib | Experimental | 10mg Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days). |
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| Placebo | Placebo Comparator | Placebo matching Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib | Drug | Administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Clinically Significant Event(s) | Clinically significant events were defined as a moderate to severe adverse event, abnormal clinical sign, or clinical laboratory finding that may pose risk to the well-being of the participant. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module. | Baseline through Study Completion (up to Day 20) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics(PK): Maximum Concentration (Cmax) of Baricitinib | Maximum observed drug concentration for single dose and Cmax as steady date for multiple dosing. | Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose; Day 5: Predose; Day 6: Predose; Day 7: Predose; Day 8: Predose; Day 9: Predose; Day 10: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Beijing | 100034 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo matching baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days). |
| FG001 | 2mg Baricitinib | 2mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days). |
| FG002 | 4mg Baricitinib | 4mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days). |
| FG003 | 10mg Baricitinib | 10mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment |
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| Follow-up |
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All randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo matching baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days). |
| BG001 | 2mg Baricitinib | 2mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days). |
| Units | Counts |
|---|---|
| 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 | Number of Participants With One or More Clinically Significant Event(s) | Clinically significant events were defined as a moderate to severe adverse event, abnormal clinical sign, or clinical laboratory finding that may pose risk to the well-being of the participant. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module. | All randomized participants who received at least one dose of study drug and experienced clinically significant event. | Posted | Count of Participants | Participants | No | Baseline through Study Completion (up to Day 20) |
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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 | Placebo | Placebo matching baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5079 |
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| ID | Term |
|---|---|
| C000596027 | baricitinib |
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| Placebo | Drug | Administered orally. |
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| Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Baricitinib | Area under the concentration versus time curve from zero to infinity (AUC0-inf) during single dose and area under the concentration versus time curve (AUCtau,ss) during multiple dose of baricitinib at steady state. | Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose; Day 5: Predose; Day 6: Predose; Day 7: Predose; Day 8: Predose; Day 9: Predose; Day 10: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose |
| China |
| Withdrawal by Subject |
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| COMPLETED |
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| NOT COMPLETED |
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| BG002 | 4mg Baricitinib | 4mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days). |
| BG003 | 10mg Baricitinib | 10mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days). |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
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| 2mg Baricitinib |
2mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days). |
| OG002 | 4mg Baricitinib | 4mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days). |
| OG003 | 10mg Baricitinib | 10mg baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days). |
|
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| Secondary | Pharmacokinetics(PK): Maximum Concentration (Cmax) of Baricitinib | Maximum observed drug concentration for single dose and Cmax as steady date for multiple dosing. | All randomized participants who received at least one dose of baricitinib and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose; Day 5: Predose; Day 6: Predose; Day 7: Predose; Day 8: Predose; Day 9: Predose; Day 10: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose |
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|
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| Secondary | Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Baricitinib | Area under the concentration versus time curve from zero to infinity (AUC0-inf) during single dose and area under the concentration versus time curve (AUCtau,ss) during multiple dose of baricitinib at steady state. | All randomized participants who received at least 1 dose of baricitinib and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram * hour per milliliter (ng*h/mL) | Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose; Day 5: Predose; Day 6: Predose; Day 7: Predose; Day 8: Predose; Day 9: Predose; Day 10: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose |
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| 0 |
| 8 |
| 4 |
| 8 |
| EG001 | 2mg Baricitinib | 2mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days). | 0 | 8 | 1 | 8 |
| EG002 | 4mg Baricitinib | 4mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days). | 0 | 9 | 2 | 9 |
| EG003 | 10mg Baricitinib | 10mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days). | 0 | 8 | 4 | 8 |
| Aspartate aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Blood uric acid increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Electrocardiogram abnormal | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Protein urine present | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
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| Multiple Dose Day 10 |
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| Multiple Dose Day 10 |
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