Pharmacokinetic Study to Evaluate the Effect of a Single Dose of Guselkumab (CNTO 1959) on CYP 450 Enzyme Activities After Subcutaneous Administration in Participants With Psoriasis

Phase 1 Completed 16 enrolled Janssen Research & Development, LLC

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the potential effects of a single dose of 200 milligram (mg) guselkumab on the plasma concentrations of a cocktail of representative probe substrates of Cytochrome P450 isozymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2) in participants with moderate to severe psoriasis.

Timeline

Start: 2015-06-18
Primary completion: 2016-08-31
Completion: 2016-08-31

Publications

Zhu Y, Xu Y, Zhuang Y, Piantone A, Shu C, Chen D, Zhou H, Xu Z, Sharma A. Evaluating Potential Disease-Mediated Protein-Drug Interactions in Patients With Moderate-to-Severe Plaque Psoriasis Receiving Subcutaneous Guselkumab. Clin Transl Sci. 2020 Nov;13(6):1217-1226. doi: 10.1111/cts.12807. Epub 2020 May 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Caffeine	Small molecule	100 mg	Oral
Subject	Dextromethorphan	Unknown	30 mg	Oral
Subject	Guselkumab	Monoclonal antibody	200 mg	Subcutaneous
Subject	Midazolam	Small molecule	0.03 mg/kg	Oral
Subject	Omeprazole	Other / unclassified	20 mg	Oral
Subject	Warfarin	Small molecule	10 mg	Oral

Pharmacokinetic Study to Evaluate the Effect of a Single Dose of Guselkumab (CNTO 1959) on CYP 450 Enzyme Activities After Subcutaneous Administration in Participants With Psoriasis

Summary

Timeline

Publications

Drugs

Indications