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

Completed · Phase 1

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT02397382

Run by

Janssen Research & Development, LLC

People needed

16

Starts

2015-06-18

Expected to finish

2016-08-31

Last updated by the study team

2017-09-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis (PsA) for at least 6 months before Day 1
• Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (>=) 12 at Screening
• Have an Investigator's Global Assessment (IGA) >= 3 at Screening
• Have an involved body surface area (BSA) >= 10 percent (%) at Screening
• Be a candidate for phototherapy or systemic treatment for psoriasis

You may not qualify if…

• Has a history of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac (including unstable cardiovascular disease, defined as a recent clinical deterioration (example, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months), vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, bleeding disorder, rheumatologic, psychiatric, or metabolic disturbances
• Have a pulse oximetry value less than (<) 94 % at Screening
• Genetically determined poor metabolizers of CYP2C9, CYP2C19, and CYP2D6 substrates
• Is currently undergoing or has previously undergone allergy immunotherapy for a history of anaphylactic reactions
• Has a transplanted organ (with exception of a corneal transplant greater than (>) 3 months before Day 1)

Where it is running

• Study site — Anniston, Alabama, United States
• Study site — North Hollywood, California, United States
• Study site — Orlando, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — High Point, North Carolina, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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