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

NCT02760615 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2020-10-27

No results posted yet for this study

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.

Conditions

  • Colitis, Ulcerative
  • Crohn Disease

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-01
Primary Completion
2020-08-01
Completion
2020-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02760615 on ClinicalTrials.gov