Psoriasis Clinical Trial
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
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.
Full Description
This is an open-label, multi-center study. The total duration of study will be approximately 17 weeks per participant, including Screening phase (up to 4 weeks prior to first probe cocktail administration). Participants will have 4 in-patient periods on Day 1, 8, 15 and 36 (3 periods consisting of 3 days and 2 nights each and 1 consisting of 2 days and 1 night) followed by follow up period (up to Day 92). All Participants will receive a single 200 mg subcutaneous (SC) injection (2*100 mg) of guselkumab on Day 8 and probe cocktail on Days 1, 15 and 36. Blood samples will be collected for the evaluation of pharmacokinetics and immunogenicity at pre-dose and post-dose of study treatment. Participants' safety will be monitored throughout the study.
Eligibility 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)
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There is 1 Location for this study
Anniston Alabama, , United States
North Hollywood California, , United States
Orlando Florida, , United States
Atlanta Georgia, , United States
High Point North Carolina, , United States
Duncansville Pennsylvania, , United States
Pittsburgh Pennsylvania, , United States
San Antonio Texas, , United States
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