Overview

A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis

Status:
Recruiting

Trial end date:
2024-10-01

Target enrollment:

Participant gender:

Summary

The purpose of this study is to evaluate the potential effects of an intravenous (IV) induction and subcutaneous (SC) maintenance administration of ustekinumab on the pharmacokinetic (PK) of a cocktail of representative probe substrates of cytochrome P450 (CYP) enzymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2) in participants with Active Crohn's disease (CD) or Ulcerative Colitis (UC).

Phase:

Phase 1

Details

Lead Sponsor:

Janssen Research & Development, LLC

Treatments:

Caffeine
Dextromethorphan
Midazolam
Omeprazole
Ustekinumab
Vitamin K
Vitamins
Warfarin