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

September 19, 2017 updated by: Janssen Research & Development, LLC

A Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Guselkumab (CNTO 1959) on Cytochrome P450 Enzyme Activities Following a Single Subcutaneous Administration in Subjects With Moderate to Severe Plaque-type Psoriasis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Guselkumab and Cytochrome P450 Probe Cocktail
Participants will be administered single dose of Guselkumab 200 milligram (mg) by subcutaneous injection (2*100 mg) on Day 8 and Cytochrome P450 probe cocktail consist of midazolam, warfarin/vitamin K, omeprazole, dextromethorphan and caffeine orally once on Day 1,15 and 36.
Drug: Guselkumab
Guselkumab will be administered as a single dose of 200 milligram (mg) by subcutaneous injection (2*100 mg) on Day 8.
Drug: Midazolam
Midazolam will be administered orally as probe cocktail containing 0.03 mg per kilogram (kg) once on Day 1, 15 and 36.
Drug: Warfarin
Warfarin will be administered orally as probe cocktail containing 10 mg once on Day 1, 15 and 36.
Drug: Omeprazole
Omeprazole will be administered orally as probe cocktail containing 20 mg once on Day 1, 15 and 36.
Drug: Dextromethorphan
Dextromethorphan will be administered orally as probe cocktail containing 30 mg once on Day 1, 15 and 36.
Drug: Caffeine
Caffeine will be administered orally as probe cocktail containing 100 mg once on Day 1, 15 and 36.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Screening up to 96 hours on Day 1, 15 and 36
The Cmax is the maximum observed plasma concentration of Midazolam, Omeprazole, Dextromethorphan, Caffeine and S-warfarin.
Screening up to 96 hours on Day 1, 15 and 36
Time to Reach Maximum Concentration (Tmax)
Time Frame: Screening up to 96 hours on Day 1, 15 and 36
The Tmax is time to reach the maximum observed plasma concentration of Midazolam, Omeprazole, Dextromethorphan, Caffeine and S-warfarin.
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])
Time Frame: Screening up to 96 hours on Day 1, 15 and 36
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.
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])
Time Frame: Screening up to 96 hours on Day 1, 15 and 36
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to extrapolated infinite time.
Screening up to 96 hours on Day 1, 15 and 36
Serum Concentration of Guselkumab
Time Frame: Pre-dose on Day 8 and up to Day 92
The observed serum concentration of Guselkumab.
Pre-dose on Day 8 and up to Day 92
Number of Participants with antibody to CNTO1959
Time Frame: Pre-dose on Day 8 and up to Day 92
The frequency of anti-CNTO1959 antibodies.
Pre-dose on Day 8 and up to Day 92

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Up to 92 Days
The incidence of TEAEs and SAEs from the screening visit and until the follow-up contact will be will be summarized by treatment period.
Up to 92 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2015

Primary Completion (Actual)

August 31, 2016

Study Completion (Actual)

August 31, 2016

Study Registration Dates

First Submitted

March 19, 2015

First Submitted That Met QC Criteria

March 19, 2015

First Posted (Estimate)

March 25, 2015

Study Record Updates

Last Update Posted (Actual)

September 20, 2017

Last Update Submitted That Met QC Criteria

September 19, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR106796
  • CNTO1959PSO1003 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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