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
Stopped early · Phase 1
Conditions studied: Crohn Disease, Ulcerative Colitis
In brief
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).
Key facts
- Study ID
- NCT03358706
- Run by
- Janssen Research & Development, LLC
- People needed
- 28
- Starts
- 2018-02-02
- Expected to finish
- 2021-11-22
- Last updated by the study team
- 2025-08-21
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
Where it is running
- WCCT Global, LLC — Cypress, California, United States
- Ocean Blue Medical Research Center Inc. — Miami Springs, Florida, United States
- Duke University — Durham, North Carolina, United States
- Ghent University Hospital — Ghent, Belgium
- Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman — Liège, Belgium
- Az Sint-Maarten — Mechelen, Belgium
- Clinical Pharmacology Unit — Merksem, Belgium
- Universitatsklinikum Bonn — Bonn, Germany
- Universitatsklinikum Essen — Essen, Germany
- Universitatsklinikum Freiburg — Freiburg im Breisgau, Germany
- CTC North GmbH & Co. KG, Am Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany
- Clinical Research Center Hannover — Hanover, Germany
- University Hospital Heidelberg — Heidelberg, Germany
- Wythenshawe Hospital — Greater Manchester, United Kingdom
- Royal Liverpool University Hospital — Liverpool, United Kingdom
- Guy's Hospital — London, United Kingdom
Full record on ClinicalTrials.gov
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