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

Phase 1 Terminated 28 enrolled Janssen Research & Development, LLC

Non-randomizedParallel-groupOpen-labelOther

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).

Timeline

Start: 2018-02-02
Primary completion: 2021-11-22
Completion: 2021-11-22

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Caffeine	Small molecule	100 mg	Oral
Subject	Dextromethorphan	Unknown	30 mg	Oral
Subject	Midazolam	Small molecule	2 mg	Oral
Subject	Omeprazole	Other / unclassified	20 mg	Oral
Subject	Ustekinumab	Monoclonal antibody	90 mg	Intravenous
Subject	Vitamin K	Unknown	10 mg	Oral
Subject	Warfarin	Small molecule	10 mg	Oral

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

Summary

Timeline

Drugs

Indications