NCT02760615

Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study

An Open-Label, 2-Part, Multicenter, Post-marketing Study to Evaluate the Effect of Moderately or Severely Active Ulcerative Colitis or Crohn's Disease on Cytochrome P-450 Enzyme Substrates Compared to Healthy Subjects and the Effect of Vedolizumab Treatment on Cytochrome P-450 Enzyme Substrates in Subjects With Ulcerative Colitis or Crohn's Disease

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The drug being tested in this study is called vedolizumab, which is being tested to assess the possibility of drug-drug interactions when administered with other medications. The study will comprise of 2 parallel parts: Part 1 and Part 2. Part 1 will enroll approximately 40 participants: 20 healthy participants and 20 participants with UC or CD who are not currently being treated with vedolizumab. All participants will receive the following medications: * Caffeine 100 mg * Losartan 50 mg * Omeprazole 20 mg * Dextromethorphan 30 mg * Midazolam 2 mg Part 2 will enroll approximately 20 participants on established vedolizumab intravenous (IV) maintenance treatment of 300 mg for the treatment of UC or CD. Participants will receive the same medications and dosages as in Part 1 in addition to their scheduled vedolizumab 300 mg IV. This multi-center trial will be conducted in the United States. For Part 1 and Part 2, participants will arrive at study unit for check-in (Day -1) and will return to the study unit for dosing and PK assessment on Day 1 and study exit on Day 2 or will be kept from Check-in through at least 24 hours after dosing for safety and PK assessments before discharge. The total confinement period (optional) will be up to 3 days for both the parts. The overall time to participate for each participant in Part 1 will be approximately 6 weeks and for Part 2, it will be approximately 12 weeks.

Conditions

• Colitis, Ulcerative
• Crohn Disease

Interventions

Type	Name	Description
DRUG	Caffeine	Caffeine tablets
DRUG	Losartan	Losartan tablets
DRUG	Omeprazole	Omeprazole capsules
DRUG	Dextromethorphan	Dextromethorphan capsules
DRUG	Midazolam	Midazolam syrup
DRUG	Vedolizumab	Vedolizumab solution for IV infusion

Timeline

• Start date: 2016-11-01
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2016-05-03
• Last updated: 2020-10-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study