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| ID | Type | Description | Link |
|---|---|---|---|
| I6T-MC-AMBP | Other Identifier | Eli Lilly and Company |
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This study is known as a "drug interaction study." The purpose is to learn how commonly used drugs or substances (midazolam, warfarin, dextromethorphan, omeprazole, and caffeine) and their breakdown products get into the bloodstream after taking a "cocktail" (combination) of them before and after multiple doses of mirikizumab.
The study will last about 23 weeks for each participant. Screening must be completed within 4 weeks prior to study start.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Cocktail | Experimental | Period 1: Participants received a single dose of the following drug cocktail on Day 1: 1 mg midazolam, 10 mg warfarin, 10 mg vitamin K, 30 mg dextromethorphan, 20 mg omeprazole, 100 mg Caffeine administered orally |
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| Mirikizumab + Drug Cocktail | Experimental | Period 2: Participants received 250 mg mirikizumab subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks (Days 1 to Day 113) Period 2: Participants received the second dose of the drug cocktail: 1 mg midazolam, 10 mg warfarin, 10 mg vitamin K, 30 mg dextromethorphan, 20 mg omeprazole, 100 mg caffeine administered orally on Day 116. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug Cocktail | Drug | Drug cocktail consists of caffeine, warfarin plus vitamin K, omeprazole, dextromethorphan, and midazolam, administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Midazolam | Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours; post-dose |
| PK: Cmax of Warfarin | PK: Cmax of Warfarin | Period 1: Day 1: predose,1,2, 4,6, 8 and 10 hours, Day 2: 24 hours, Day 3: 48 hours, Day 4: 72 hours, Day 5: 96 hours; Period 2: Day 116: predose,1,2,4,6,8 and 10 hours, Day 117: 24 hours, Day 118: 48 hours, Day 119: 72 hours, Day 120: 96 hours;post-dose |
| PK: Cmax of Dextromethorphan | PK: Cmax of Dextromethorphan | Period 1: Day 1: predose, 1, 2, 4, 6, 8 and 10 hours, Day 2: 24 hours, Day 3: 48 hours, Day 4: 72 hours; Period 2: Day 116: predose, 1, 2,4, 6, 8 and 10 hours, Day 117: 24 hours, Day 118: 48 hours, Day 119: 72 hours;post-dose |
| PK: Cmax of Omeprazole | PK: Cmax of Omeprazole | Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours, Day 3: 48 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours, Day 118: 48 hours;post-dose |
| PK: Cmax of Caffeine | PK: Cmax of Caffeine | Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours, Day 3: 48 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours, Day 118: 48 hours;post-dose |
| PK: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC [0-∞]) of Midazolam |
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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 |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| Avail Clinical Research LLC |
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| ID | Title | Description |
|---|---|---|
| FG000 | Drug Cocktail | Period 1: Participants received a single dose of the following drug cocktail on Day 1: 1 mg midazolam, 10 mg warfarin, 10 mg vitamin K, 30 mg dextromethorphan, 20 mg omeprazole, 100 mg Caffeine administered orally. |
| FG001 | Mirikizumab + Drug Cocktail | Period 2: Participants received 250 mg mirikizumab subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks (Days 1 to Day 113). Period 2: Participants received the second dose of the drug cocktail: 1 mg midazolam, 10 mg warfarin, 10 mg vitamin K, 30 mg dextromethorphan, 20 mg omeprazole, 100 mg caffeine administered orally on Day 116. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (6 Days) |
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| Period 2 (120 Days) |
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All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Drug Cocktail Period 1: Participants received a single dose of the following drug cocktail on Day 1: 1 mg midazolam, 10 mg warfarin, 10 mg vitamin K, 30 mg dextromethorphan, 20 mg omeprazole, 100 mg Caffeine administered orally. Mirikizumab + Drug Cocktail Period 2: Participants received 250 mg mirikizumab subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks (Days 1 to Day 113) Period 2: Participants received the second dose of the drug cocktail: 1 mg midazolam, 10 mg warfarin, 10 mg vitamin K, 30 mg dextromethorphan, 20 mg omeprazole, 100 mg caffeine administered orally on Day 116. |
| 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 | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Midazolam | All participants who received at least one dose of study drug cocktail and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per millilitre (ng/mL) | Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours; post-dose |
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Baseline Up To 144 Days
All Participants who received at least one dose of study drug.
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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 | Period 1: Drug Cocktail | Period 1: Participants received a single dose of the following drug cocktail on Day 1: 1 mg midazolam, 10 mg warfarin, 10 mg vitamin K, 30 mg dextromethorphan, 20 mg omeprazole, 100 mg Caffeine administered orally. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 9, 2018 | Sep 11, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 4, 2018 | Sep 11, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000708407 | mirikizumab |
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| Mirikizumab | Drug | Administered SC |
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PK: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC [0-∞]) of Midazolam
| Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours;post-dose |
| PK: AUC Time Zero to Infinity (AUC[0-∞]) of Warfarin | PK: AUC Time Zero to Infinity (AUC[0-∞]) of Warfarin | Period 1: Day 1: predose,1,2,4,6,8 and 10 hours, Day 2: 24 hours, Day 3: 48 hours, Day 4: 72 hours, Day 5: 96 hours; Period 2: Day 116: predose, 1, 2, 4, 6, 8 and 10 hours, Day 117: 24 hours, Day 118: 48 hours,Day 119: 72 hours,Day 120: 96 hours;post-dose |
| PK: AUC Time Zero to Infinity (AUC[0-∞]) of Dextromethorphan | PK: AUC Time Zero to Infinity (AUC[0-∞]) of Dextromethorphan | Period 1: Day 1: predose,1,2,4,6,8 and 10 hours, Day 2: 24 hours, Day 3: 48 hours, Day 4: 72 hours; Period 2: Day 116: predose, 1, 2,4, 6, 8 and 10 hours, Day 117: 24 hours, Day 118: 48 hours, Day 119: 72 hours;post-dose |
| PK: AUC Time Zero to Infinity (AUC[0-∞]) of Omeprazole | PK: AUC Time Zero to Infinity (AUC[0-∞]) of Omeprazole | Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours, Day 3: 48 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours, Day 118: 48 hours;post-dose |
| PK: AUC Time Zero to Infinity (AUC[0-∞]) of Caffeine | PK: AUC Time Zero to Infinity (AUC[0-∞]) of Caffeine | Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours, Day 3: 48 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours, Day 118: 48 hours;post-dose |
| DeLand |
| Florida |
| 32720 |
| United States |
| High Point Clinical Trials Center | High Point | North Carolina | 27265 | United States |
| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | 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 |
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Period 2: Participants received 1 mg midazolam administered orally on day 116.
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| Primary | PK: Cmax of Warfarin | PK: Cmax of Warfarin | All participants who received at least one dose of study drug cocktail and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Period 1: Day 1: predose,1,2, 4,6, 8 and 10 hours, Day 2: 24 hours, Day 3: 48 hours, Day 4: 72 hours, Day 5: 96 hours; Period 2: Day 116: predose,1,2,4,6,8 and 10 hours, Day 117: 24 hours, Day 118: 48 hours, Day 119: 72 hours, Day 120: 96 hours;post-dose |
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| Primary | PK: Cmax of Dextromethorphan | PK: Cmax of Dextromethorphan | All participants who received at least one dose of study drug cocktail and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Period 1: Day 1: predose, 1, 2, 4, 6, 8 and 10 hours, Day 2: 24 hours, Day 3: 48 hours, Day 4: 72 hours; Period 2: Day 116: predose, 1, 2,4, 6, 8 and 10 hours, Day 117: 24 hours, Day 118: 48 hours, Day 119: 72 hours;post-dose |
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| Primary | PK: Cmax of Omeprazole | PK: Cmax of Omeprazole | All participants who received at least one dose of study drug cocktail and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours, Day 3: 48 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours, Day 118: 48 hours;post-dose |
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| Primary | PK: Cmax of Caffeine | PK: Cmax of Caffeine | All participants who received at least one dose of study drug cocktail and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours, Day 3: 48 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours, Day 118: 48 hours;post-dose |
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| Primary | PK: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC [0-∞]) of Midazolam | PK: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC [0-∞]) of Midazolam | All participants who received at least one dose of study drug cocktail and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms hour per millilitre (ng*h/mL) | Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours;post-dose |
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| Primary | PK: AUC Time Zero to Infinity (AUC[0-∞]) of Warfarin | PK: AUC Time Zero to Infinity (AUC[0-∞]) of Warfarin | All participants who received at least one dose of study drug cocktail and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Period 1: Day 1: predose,1,2,4,6,8 and 10 hours, Day 2: 24 hours, Day 3: 48 hours, Day 4: 72 hours, Day 5: 96 hours; Period 2: Day 116: predose, 1, 2, 4, 6, 8 and 10 hours, Day 117: 24 hours, Day 118: 48 hours,Day 119: 72 hours,Day 120: 96 hours;post-dose |
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| Primary | PK: AUC Time Zero to Infinity (AUC[0-∞]) of Dextromethorphan | PK: AUC Time Zero to Infinity (AUC[0-∞]) of Dextromethorphan | All participants who received at least one dose of study drug cocktail and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Period 1: Day 1: predose,1,2,4,6,8 and 10 hours, Day 2: 24 hours, Day 3: 48 hours, Day 4: 72 hours; Period 2: Day 116: predose, 1, 2,4, 6, 8 and 10 hours, Day 117: 24 hours, Day 118: 48 hours, Day 119: 72 hours;post-dose |
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| Primary | PK: AUC Time Zero to Infinity (AUC[0-∞]) of Omeprazole | PK: AUC Time Zero to Infinity (AUC[0-∞]) of Omeprazole | All participants who received at least one dose of study drug cocktail and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours, Day 3: 48 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours, Day 118: 48 hours;post-dose |
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| Primary | PK: AUC Time Zero to Infinity (AUC[0-∞]) of Caffeine | PK: AUC Time Zero to Infinity (AUC[0-∞]) of Caffeine | All participants who received at least one dose of study drug cocktail and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours, Day 3: 48 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours, Day 118: 48 hours;post-dose |
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| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Period 2: Mirikizumab | Period 2: Participants received 250 mg mirikizumab subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks (Days 1 to Day 113). | 0 | 29 | 0 | 29 | 3 | 29 |
| EG002 | Period 2: Drug Cocktail | Period 2: Participants received the second dose of the drug cocktail: 1 mg midazolam, 10 mg warfarin, 10 mg vitamin K, 30 mg dextromethorphan, 20 mg omeprazole, 100 mg caffeine administered orally on Day 116. | 0 | 29 | 0 | 29 | 0 | 29 |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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