Clincosm LogoSign in Get a demo

A Study of Mirikizumab in Participants With Plaque Psoriasis

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT03718884
Collaborator
(none)
26
Enrollment
3
Locations
2
Arms
12.2
Actual Duration (Months)
8.7
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Evaluation of the Effect of Mirikizumab on the Pharmacokinetics of Cytochrome P450 Substrates in Patients With Moderate-to-Severe Plaque Psoriasis
Actual Study Start Date :
Oct 23, 2018
Actual Primary Completion Date :
Oct 28, 2019
Actual Study Completion Date :
Oct 28, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Drug Cocktail

Drug cocktail administered orally once in Period 1

Drug: Drug Cocktail
Drug cocktail consists of caffeine, warfarin plus vitamin K, omeprazole, dextromethorphan, and midazolam, administered orally
Experimental: Mirikizumab + Drug Cocktail

Drug cocktail administered orally once in Period 2 (day 116). Mirikizumab administered subcutaneously (SC) on multiple occasions in Period 2.

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

Drug: Mirikizumab
Administered SC
Other Names:
  • LY3074828

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Midazolam [Period 1, Day 1 Predose through Period 2, Day 117]

      PK: Cmax of Midazolam

    2. PK: Cmax of Warfarin [Period 1, Day 1 Predose through Period 2, Day 120]

      PK: Cmax of Warfarin

    3. PK: Cmax of Dextromethorphan [Period 1, Day 1 Predose through Period 2, Day 119]

      PK: Cmax of Dextromethorphan

    4. PK: Cmax of Omepraxole [Period 1, Day 1 Predose through Period 2, Day 118]

      PK: Cmax of Omepraxole

    5. PK: Cmax of Caffeine [Period 1, Day 1 Predose through Period 2, Day 118]

      PK: Cmax of Caffeine

    6. PK: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC [0-∞]) of Midazolam [Period 1, Day 1 Predose through Period 2, Day 117]

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

    7. PK: AUC Time Zero to Infinity (AUC[0-∞]) of Warfarin [Period 1, Day 1 Predose through Period 2, Day 120]

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

    8. PK: AUC Time Zero to Infinity (AUC[0-∞]) of Dextromethorphan [Period 1, Day 1 Predose through Period 2, Day 119]

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

    9. PK: AUC Time Zero to Infinity (AUC[0-∞]) of Omepraxole [Period 1, Day 1 Predose through Period 2, Day 118]

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

    10. PK: AUC Time Zero to Infinity (AUC[0-∞]) of Caffeine [Period 1, Day 1 Predose through Period 2, Day 118]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anaheim Clinical Trials, LLC Anaheim California United States 92801
    2 Avail Clinical Research LLC DeLand Florida United States 32720
    3 High Point Clinical Trials Center High Point North Carolina United States 27265

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03718884
    Other Study ID Numbers:
    • 17117
    • I6T-MC-AMBP
    First Posted:
    Oct 25, 2018
    Last Update Posted:
    Dec 24, 2019
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Psoriasis
    Mirikizumab

    Study Results

    No Results Posted as of Dec 24, 2019