A Study of Mirikizumab in Participants With Plaque Psoriasis

Eli Lilly and Company29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Psoriasis

Interventions

Drug CocktailDRUG

Drug cocktail consists of caffeine, warfarin plus vitamin K, omeprazole, dextromethorphan, and midazolam, administered orally

MirikizumabDRUG

Administered SC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Avail Clinical Research LLC

DeLand, Florida, United States

High Point Clinical Trials Center

High Point, North Carolina, United States

Outcomes

Primary Outcomes

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Midazolam

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

PK: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC \[0-∞\]) of Midazolam

Time frame: 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

Data from ClinicalTrials.gov

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