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CompletedNCT03718884Updated Jan 29, 2024Results posted

A Study of Mirikizumab in Participants With Plaque Psoriasis

A Phase 1 interventional study of Drug Cocktail and Mirikizumab in Psoriasis, sponsored by Eli Lilly and Company. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-29.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
29
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 29 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • 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

  • 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: Drug Cocktail · Drug: Mirikizumab

Interventions

  • DrugDrug Cocktail

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

  • DrugMirikizumab

    Administered SC

    Also known as: LY3074828

06

What researchers measure

Primary outcomes

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

    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

  2. PK: Cmax of Warfarin

    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

  3. PK: Cmax of Dextromethorphan

    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

  4. PK: Cmax of Omeprazole

    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

  5. PK: Cmax of Caffeine

    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

  6. 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

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

    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

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

    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

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

    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

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

    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

07

Results

Posted Jan 29, 2024

Participant flow

Period 1 (6 Days)
Participant flow — Period 1 (6 Days)
MilestoneDrug CocktailMirikizumab + Drug Cocktail
Started290
Received at least one dose of study drug290
Completed290
Not completed00
Period 2 (120 Days)
Participant flow — Period 2 (120 Days)
MilestoneDrug CocktailMirikizumab + Drug Cocktail
Started029
Completed026
Not completed03
Withdrew: Withdrawal by subject01
Withdrew: Lost to follow-up02

Outcome measures

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

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
Reported as:
Geometric mean · Nanograms per millilitre (ng/mL)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Midazolam
Nanograms per millilitre (ng/mL)Period 1: 1 mg MidazolamPeriod 2: 1 mg Midazolam
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Midazolam4.07 ± 294.46 ± 35
PrimaryPK: Cmax of Warfarin

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
Reported as:
Geometric mean · ng/mL
PK: Cmax of Warfarin
ng/mLPeriod 1: 10 mg WarfarinPeriod 2: 10 mg Warfarin
PK: Cmax of Warfarin543 ± 18506 ± 23
PrimaryPK: Cmax of Dextromethorphan

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
Reported as:
Geometric mean · ng/mL
PK: Cmax of Dextromethorphan
ng/mLPeriod 1: 30 mg DextromethorphanPeriod 2: 30 mg Dextromethorphan
PK: Cmax of Dextromethorphan1.60 ± 1541.47 ± 118
PrimaryPK: Cmax of Omeprazole

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
Reported as:
Geometric mean · ng/mL
PK: Cmax of Omeprazole
ng/mLPeriod 1: 20 mg OmeprazolePeriod 2: 20 mg Omeprazole
PK: Cmax of Omeprazole369 ± 137437 ± 81
PrimaryPK: Cmax of Caffeine

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
Reported as:
Geometric mean · ng/mL
PK: Cmax of Caffeine
ng/mLPeriod 1: 100 mg CaffeinePeriod 2: 100 mg Caffeine
PK: Cmax of Caffeine2400 ± 192340 ± 26
PrimaryPK: 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
Reported as:
Geometric mean · Nanograms hour per millilitre (ng*h/mL)
PK: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC [0-∞]) of Midazolam
Nanograms hour per millilitre (ng*h/mL)Period 1: 1 mg MidazolamPeriod 2: 1 mg Midazolam
PK: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC [0-∞]) of Midazolam13.4 ± 4315.6 ± 40
PrimaryPK: AUC Time Zero to Infinity (AUC[0-∞]) of Warfarin

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
Reported as:
Geometric mean · ng*h/mL
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Warfarin
ng*h/mLPeriod 1: 10 mg WarfarinPeriod 2: 10 mg Warfarin
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Warfarin14800 ± 3413800 ± 31
PrimaryPK: AUC Time Zero to Infinity (AUC[0-∞]) of Dextromethorphan

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
Reported as:
Geometric mean · ng*h/mL
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Dextromethorphan
ng*h/mLPeriod 1: 30 mg DextromethorphanPeriod 2: 30 mg Dextromethorphan
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Dextromethorphan14.6 ± 16013.0 ± 132
PrimaryPK: AUC Time Zero to Infinity (AUC[0-∞]) of Omeprazole

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
Reported as:
Geometric mean · ng*h/mL
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Omeprazole
ng*h/mLPeriod 1: 20 mg OmeprazolePeriod 2: 20 mg Omeprazole
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Omeprazole1280 ± 1421530 ± 103
PrimaryPK: AUC Time Zero to Infinity (AUC[0-∞]) of Caffeine

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
Reported as:
Geometric mean · ng*h/mL
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Caffeine
ng*h/mLPeriod 1: 100 mg CaffeinePeriod 2: 100 mg Caffeine
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Caffeine19700 ± 4620800 ± 48

Adverse events

Collected over Baseline Up To 144 Days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Period 1: Drug Cocktail0/29 (0%)0/29 (0%)0/29 (0%)
Period 2: Mirikizumab0/29 (0%)0/29 (0%)3/29 (10.3%)
Period 2: Drug Cocktail0/29 (0%)0/29 (0%)0/29 (0%)
Most frequent other events
Most frequent other events
EventPeriod 1: Drug CocktailPeriod 2: MirikizumabPeriod 2: Drug Cocktail
Hand fractureInjury, poisoning and procedural complications0/292/290/29
Limb injuryInjury, poisoning and procedural complications0/292/290/29

Baseline characteristics

All participants who received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)All Participants
Mean52.1 (31 to 79)
Sex: Female, Male
Sex: Female, Male(Participants)All Participants
Female5
Male24
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)All Participants
Hispanic or Latino11
Not Hispanic or Latino18
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Participants
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American4
White24
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)All Participants
United States29
08

Study locations

3 sites
  • Anaheim Clinical Trials, LLC
    Anaheim, California 92801, United States
  • Avail Clinical Research LLC
    DeLand, Florida 32720, United States
  • High Point Clinical Trials Center
    High Point, North Carolina 27265, United States
09

References and documents

Study documents

  • Study protocol · Aug 9, 2018
  • Statistical analysis plan · Sep 4, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03718884
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Oct 25, 2018
Start date
Oct 23, 2018
Primary completion
Oct 28, 2019
Completion
Oct 28, 2019
Results posted
Jan 29, 2024
Last update
Jan 29, 2024

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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