A Study of Mirikizumab in Participants With Plaque Psoriasis

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03718884
• Other study ID #: 17117
• Secondary ID: I6T-MC-AMBP
• Status: Completed
• Phase: Phase 1
• Start date: October 23, 2018
• Est. completion date: October 28, 2019

Study information

• Verified date: May 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 28, 2019
• Est. primary completion date: October 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	PK: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC [0-8]) of Midazolam	PK: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC [0-8]) 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
Primary	PK: AUC Time Zero to Infinity (AUC[0-8]) of Warfarin	PK: AUC Time Zero to Infinity (AUC[0-8]) 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
Primary	PK: AUC Time Zero to Infinity (AUC[0-8]) of Dextromethorphan	PK: AUC Time Zero to Infinity (AUC[0-8]) 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
Primary	PK: AUC Time Zero to Infinity (AUC[0-8]) of Omeprazole	PK: AUC Time Zero to Infinity (AUC[0-8]) 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
Primary	PK: AUC Time Zero to Infinity (AUC[0-8]) of Caffeine	PK: AUC Time Zero to Infinity (AUC[0-8]) 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