This Study Tests the Effect of Risankizumab on the Metabolism in the Liver of Five Additional Drugs to Study Possible Drug Interactions in Patients With Psoriasis With or Without Psoriatic Arthritis
- Sponsor
- AbbVie
- Study ID
- NCT02772601
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Caffeine — DRUG
- Warfarin — DRUG
- Omeprazole — DRUG
- Metoprolol — DRUG
- Midazolam — DRUG
- Risankizumab — DRUG
Study Details
To assess the influence of risankizumab on kinetics of cytochrome P450 (CYP) probe drugs as a means of predicting drug-drug interactions.
Key Dates
- Start date
- Sep 15, 2016
- Status verified
- Sep 2017
- Primary completion
- Jun 15, 2017
- Completion
- Sep 22, 2017
Study Design
- Enrollment
- 21 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: All patients
Primary Outcome Measure
AUC0 - tz (area under the concentration-time curve) of caffeine with risankizumab in plasma over time interval from 0 to last quantifiable data point [ Time Frame: Day 98-101 ]
Related Studies
- Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy ProjectRecruiting · University of California, San Diego · La Jolla, California
- Regulation of Inflammatory Genes in PsoriasisRecruiting · University of Alabama at Birmingham · Birmingham, Alabama
- LTS of Siliq vs. Other Therapies Treating of Adults With Moderate-to-Severe PsoriasisEnrolling By Invitation · Bausch Health Americas, Inc. · Bridgewater, New Jersey
- An Open-Label, Pilot Study to Evaluate the Efficacy of Narrowband Ultraviolet-B Phototherapy Three Times Weekly for Twelve Weeks in Moderate-to-Severe Psoriasis PatientsRecruiting · Psoriasis Treatment Center of Central New Jersey · East Windsor, New Jersey