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

• Status: Completed
• Trial end date: 2016-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Caffeine; Dextromethorphan; Midazolam; Omeprazole; Warfarin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)