A Study of Mirikizumab in Participants With Plaque Psoriasis
- Registration Number
- NCT03718884
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
Inclusion Criteria
- Males and females with chronic plaque psoriasis for at least 6 months who are candidates for systemic therapy or phototherapy
- Have greater than or equal to (≥) 10 percent body surface area (BSA) involvement at screening and first admission to the clinical site
Exclusion Criteria
- Pregnant or nursing (lactating)
- History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection
- Have major surgery within 8 weeks prior to first admission to the clinical site or during the study
- Have a history of lymphoma, leukemia, or any malignancy
- Require treatment with the cocktail drugs within 14 days prior to the first administration of the drug cocktail through the end of Week 12 assessments
- Have participated in any other study with mirikizumab
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Drug Cocktail 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 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. Mirikizumab + Drug Cocktail Mirikizumab 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.
- Primary Outcome Measures
Name Time Method 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 Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Midazolam
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 Warfarin
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 Dextromethorphan
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 Omeprazole
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: Cmax of Caffeine
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: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC \[0-∞\]) of Midazolam
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 Warfarin
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 Dextromethorphan
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 Omeprazole
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 PK: AUC Time Zero to Infinity (AUC\[0-∞\]) of Caffeine
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
High Point Clinical Trials Center
🇺🇸High Point, North Carolina, United States
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Avail Clinical Research LLC
🇺🇸DeLand, Florida, United States