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

Janssen Research & Development, LLC16 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Psoriasis

Interventions

GuselkumabDRUG

Guselkumab will be administered as a single dose of 200 milligram (mg) by subcutaneous injection (2\*100 mg) on Day 8.

MidazolamDRUG

Midazolam will be administered orally as probe cocktail containing 0.03 mg per kilogram (kg) once on Day 1, 15 and 36.

WarfarinDRUG

Warfarin will be administered orally as probe cocktail containing 10 mg once on Day 1, 15 and 36.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (8)

Unnamed facility

Anniston, Alabama, United States

Unnamed facility

North Hollywood, California, United States

Unnamed facility

Orlando, Florida, United States

Unnamed facility

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration (Cmax)

The Cmax is the maximum observed plasma concentration of Midazolam, Omeprazole, Dextromethorphan, Caffeine and S-warfarin.

Time frame: Screening up to 96 hours on Day 1, 15 and 36

Time to Reach Maximum Concentration (Tmax)

The Tmax is time to reach the maximum observed plasma concentration of Midazolam, Omeprazole, Dextromethorphan, Caffeine and S-warfarin.

Time frame: Screening up to 96 hours on Day 1, 15 and 36

Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])

The AUC (0-last) is area under the plasma concentration-time curve from time zero to time of last quantifiable concentration of Midazolam, Omeprazole, Dextromethorphan, Caffeine and S-warfarin.

Time frame: Screening up to 96 hours on Day 1, 15 and 36

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - infinity])

The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to extrapolated infinite time.

Time frame: Screening up to 96 hours on Day 1, 15 and 36

Serum Concentration of Guselkumab

The observed serum concentration of Guselkumab.

Time frame: Pre-dose on Day 8 and up to Day 92

Number of Participants with antibody to CNTO1959

The frequency of anti-CNTO1959 antibodies.

Time frame: Pre-dose on Day 8 and up to Day 92

Secondary Outcomes

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Data from ClinicalTrials.gov

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