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
Phase 1
Completed
- Conditions
- Psoriasis
- Interventions
- Registration Number
- NCT02772601
- Lead Sponsor
- AbbVie
- Brief Summary
To assess the influence of risankizumab on kinetics of cytochrome P450 (CYP) probe drugs as a means of predicting drug-drug interactions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All patients Caffeine - All patients Omeprazole - All patients Midazolam - All patients Warfarin - All patients Metoprolol - All patients Risankizumab -
- Primary Outcome Measures
Name Time Method AUC0 - tz (area under the concentration-time curve) of metoprolol with risankizumab in plasma over time interval from 0 to last quantifiable data point Day 98 -100 Cmax (maximum measured concentration) of the analyte warfarin without risankizumab in plasma Day 1 AUC0 - tz (area under the concentration-time curve) of caffeine with risankizumab in plasma over time interval from 0 to last quantifiable data point Day 98-101 AUC0 - tz (area under the concentration-time curve) of caffeine without risankizumab in plasma over time interval from 0 to last quantifiable data point Day 1-3 Cmax (maximum measured concentration) of the analyte omeprazole without risankizumab in plasma Day 1 Cmax (maximum measured concentration) of the analyte warfarin with risankizumab in plasma Day 98 AUC0 - tz (area under the concentration-time curve) of warfarin without risankizumab in plasma over time interval from 0 to last quantifiable data point Day 1-8 AUC0 - tz (area under the concentration-time curve) of omeprazole with risankizumab in plasma over time interval from 0 to last quantifiable data point Day 98 - 100 AUC0 - tz (area under the concentration-time curve) of omeprazole without risankizumab in plasma over time interval from 0 to last quantifiable data point Day 1-2 AUC0 - tz (area under the concentration-time curve) of warfarin with risankizumab in plasma over time interval from 0 to last quantifiable data point Day 98 - 105 Cmax (maximum measured concentration) of the analyte omeprazole with risankizumab in plasma Day 98 AUC0 - tz (area under the concentration-time curve) of metoprolol without risankizumab in plasma over time interval from 0 to last quantifiable data point Day 1-3 AUC0 - tz (area under the concentration-time curve) of midazolam with risankizumab in plasma over time interval from 0 to last quantifiable data point Day 98 - 99 Cmax (maximum measured concentration) of the analyte metoprolol with risankizumab in plasma Day 98 Cmax (maximum measured concentration) of the analyte metoprolol without risankizumab in plasma Day 1 Cmax (maximum measured concentration) of the analyte midazolam without risankizumab in plasma Day 1 Cmax (maximum measured concentration) of the analyte caffeine without risankizumab in plasma Day 1 AUC0 - tz (area under the concentration-time curve) of midazolam without risankizumab in plasma over time interval from 0 to last quantifiable data point Day 1-2 Cmax (maximum measured concentration) of the analyte midazolam with risankizumab in plasma Day 98 Cmax (maximum measured concentration) of the analyte caffeine with risankizumab in plasma Day 98
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany