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| ID | Type | Description | Link |
|---|---|---|---|
| I4V-MC-JAGF | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to find out how the body will react to a study drug called baricitinib when taken with another drug called omeprazole.
For each participant, this study will include 2 periods in fixed order. The study will last approximately 25 days, not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baricitinib | Experimental | Baricitinib - 10 milligram (mg) tablet administered orally, once, on Day 1. |
|
| Baricitinib + Omeprazole | Experimental | Baricitinib - 10 mg tablet administered orally, once, on Day 10. Omeprazole - 40 mg capsule administered orally once daily (QD) for 8 days (Days 3 through 10). |
|
| 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 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose | |
| PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib | Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose | |
| PK: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib | Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 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, 2-period, fixed-sequence study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Baricitinib + Omeprazole | 10 milligram (mg) baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 10 in Period 2. 40 mg omeprazole capsule administered orally, once daily (QD), for 8 days (Days 3 through 10) in Period 2. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Day 1 Through Predose Day 3) |
| ||||||||||||||||
| Period 2 (At Dosing Day 3 Through Day12) |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Baricitinib + Omeprazole | 10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 10 in Period 2. 40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) 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 + omeprazole 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 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose |
|
Baseline through study completion (up to Day 24).
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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 | 10 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 |
|---|---|---|---|---|---|
| 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 |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Omeprazole | 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: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib | All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + omeprazole in Period 2) and had PK data to calculate Tmax of baricitinib. | Posted | Median | Full Range | hours | Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose |
|
|
|
| Primary | PK: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib | All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + omeprazole 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 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose |
|
|
|
| 0 |
| 30 |
| 5 |
| 30 |
| EG001 | Omeprazole | 40 mg omeprazole capsule administered orally, QD, on Days 3 through 9 in Period 2. Adverse events are reported from postdose on Day 3 through predose on Day 10. | 0 | 30 | 8 | 30 |
| EG002 | Baricitinib + Omeprazole | 10 mg baricitinib tablet administered orally once with 40 mg omeprazole capsule orally once, on Day 10 in Period 2. Adverse events are reported from postdose on Day 10 up to Day 24. | 0 | 30 | 7 | 30 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
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| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |