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OpenTrials
Completed

NCT Number: NCT03718884

A Study of Mirikizumab in Participants With 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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials, LLC, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug Cocktail

Drug

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

Mirikizumab

Drug

Administered SC

Other names: LY3074828

Primary outcomes

  1. 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

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

  2. 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 Warfarin

  3. 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 Dextromethorphan

  4. 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 Omeprazole

  5. PK: Cmax of Caffeine

    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

  6. 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

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

  7. PK: AUC Time Zero to Infinity (AUC[0-∞]) 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: AUC Time Zero to Infinity (AUC[0-∞]) of Warfarin

  8. PK: AUC Time Zero to Infinity (AUC[0-∞]) 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: AUC Time Zero to Infinity (AUC[0-∞]) of Dextromethorphan

  9. PK: AUC Time Zero to Infinity (AUC[0-∞]) 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: AUC Time Zero to Infinity (AUC[0-∞]) of Omeprazole

  10. PK: AUC Time Zero to Infinity (AUC[0-∞]) of Caffeine

    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: AUC Time Zero to Infinity (AUC[0-∞]) of Caffeine

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 25, 2018
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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