drugset / Trial / NCT02760615
Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study
Non-randomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate in a step-wise approach the disease drug-drug interaction (DDI) potential for vedolizumab to indirectly affect the exposure of cytochrome P-450 (CYP) substrate drugs by modulating pro-inflammatory cytokines in participants with ulcerative colitis (UC) or Crohn's disease (CD) who are treated with vedolizumab.
Timeline
- Start
- 2016-11-01
- Primary completion
- 2020-08-01
- Completion
- 2020-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caffeine | Small molecule | 200 mg | Oral |
| Subject | Dextromethorphan | Unknown | 30 mg | Oral |
| Subject | Losartan | Other / unclassified | 50 mg | Oral |
| Subject | Midazolam | Small molecule | 10 mg | Oral |
| Subject | Omeprazole | Other / unclassified | 40 mg | Oral |
| Subject | Vedolizumab | Monoclonal antibody | 300 mg | Intravenous |