A Study of Mirikizumab in Participants With Plaque Psoriasis

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

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 Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Mirikizumab; Drug: Drug Cocktail

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
  • Florida
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research LLC
  • North Carolina
    • High Point, North Carolina, United States, 27265
      • High Point Clinical Trials Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Drug Cocktail; Drug cocktail consists of caffeine, warfarin plus vitamin K, omeprazole, dextromethorphan, and midazolam, administered orally
Experimental: 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.	Drug: Mirikizumab; Administered SC; Other Names: LY3074828; Drug: Drug Cocktail; Drug cocktail consists of caffeine, warfarin plus vitamin K, omeprazole, dextromethorphan, and midazolam, administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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 record dates

Study Major Dates

• Study Start (Actual): October 23, 2018
• Primary Completion (Actual): October 28, 2019
• Study Completion (Actual): October 28, 2019

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 25, 2018

Study Record Updates

• Last Update Posted (Actual): January 29, 2024
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Gastrointestinal Agents; Anti-Ulcer Agents; Mirikizumab
• Other Study ID Numbers: 17117 (NSD); I6T-MC-AMBP (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No