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Clinical trial

Evaluation of the Effect of Mirikizumab on the Pharmacokinetics of Cytochrome P450 Substrates in Patients With Moderate-to-Severe Plaque Psoriasis

ID
Name
17117
Description
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.
Trial arms
Trial start
2018-10-23
Estimated PCD
2019-10-28
Trial end
2019-10-28
Status
Completed
Phase
Early phase I
Treatment
Drug Cocktail
Drug cocktail consists of caffeine, warfarin plus vitamin K, omeprazole, dextromethorphan, and midazolam, administered orally
Arms:
Drug Cocktail, Mirikizumab + Drug Cocktail
Mirikizumab
Administered SC
Arms:
Mirikizumab + Drug Cocktail
Other names:
LY3074828
Size
29
Primary endpoint
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
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
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
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
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
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
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
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
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
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
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 29, 'type': 'ACTUAL'}}
Updated at
2024-01-29

1 organization

2 products

1 indication

Organization
Eli Lilly and Company
Product
Drug Cocktail
Indication
Psoriasis
Product
Mirikizumab