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Completed

NCT Number: NCT02397382

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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anniston, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Guselkumab

Drug

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

midazolam

Drug

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

Warfarin

Drug

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

Omeprazole

Drug

Omeprazole will be administered orally as probe cocktail containing 20 mg once on Day 1, 15 and 36.

dextromethorphan

Drug

Dextromethorphan will be administered orally as probe cocktail containing 30 mg once on Day 1, 15 and 36.

Caffeine

Drug

Caffeine will be administered orally as probe cocktail containing 100 mg once on Day 1, 15 and 36.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Serum Concentration of Guselkumab

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

    The observed serum concentration of Guselkumab.

  6. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 25, 2015
Registry last updated
Sep 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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