clinical trial · NCT03358706
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
Janssen Research & Development, LLC·phase1·terminated·n = 28
Crohn DiseaseUlcerative ColitisUstekinumab IV InfusionUstekinumab SC InjectionMidazolam 2 mgWarfarin 10 mgVitamin K 10 mgOmeprazole 20 mgDextromethorphan 30 mgCaffeine 100 mg
brief 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).
started
Feb 2, 2018
primary completion
Nov 22, 2021
completion
Nov 22, 2021
last updated
Aug 21, 2025
official title
A Phase 1, Open-label, Drug Interaction 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.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol