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PsoriasisPhase 1NCT02397382

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

A Phase 1 study testing Guselkumab, Midazolam and Warfarin in people with Psoriasis, run by Janssen Research & Development, LLC at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Psoriasis
What is being tested?
Guselkumab, Midazolam and Warfarin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
8 sitesUnited States
Study dates
18 Jun 2015to 31 Aug 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Study site

    Anniston, Alabama

  • Study site

    Atlanta, Georgia

  • Study site

    Duncansville, Pennsylvania

  • Study site

    High Point, North Carolina

  • Study site

    North Hollywood, California

  • Study site

    Orlando, Florida

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    San Antonio, Texas

Other trials in United States

About this study

Official 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

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.

Read the 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.

Conditions
Psoriasis
Being tested
Guselkumab, Midazolam, Warfarin, Omeprazole, Dextromethorphan
Keywords
Psoriasis, Guselkumab, Cytochromes P450
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • OmeprazoleDrug

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

  • DextromethorphanDrug

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

  • CaffeineDrug

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

Study groups in NCT02397382
Study groupRoleWhat they receive
Guselkumab and Cytochrome P450 Probe CocktailExperimentalParticipants 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.
Receives: Drug: Guselkumab; Drug: Midazolam; Drug: Warfarin; Drug: Omeprazole; Drug: Dextromethorphan; Drug: Caffeine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Plasma Concentration (Cmax)

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

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. Serum Concentration of Guselkumab

    The observed serum concentration of Guselkumab.

    Measured: Pre-dose on Day 8 and up to Day 92

  6. Number of Participants with antibody to CNTO1959

    The frequency of anti-CNTO1959 antibodies.

    Measured: Pre-dose on Day 8 and up to Day 92

Secondary outcomes (1)

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

    The incidence of TEAEs and SAEs from the screening visit and until the follow-up contact will be will be summarized by treatment period.

    Measured: Up to 92 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2015 (estimated)
  2. Study start18 Jun 2015
  3. Primary completion31 Aug 2016
  4. Study completion31 Aug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02397382
Sponsor's protocol ID
CR106796
Other IDs
CNTO1959PSO1003
Status last verified
Sep 2017
First submitted
19 Mar 2015
Last updated
20 Sep 2017
Results posted
No
Data monitoring committee
No
FDA-regulated device
No

Publications

  • Zhu Y, Xu Y, Zhuang Y, Piantone A, Shu C, Chen D, Zhou H, Xu Z, Sharma A. Evaluating Potential Disease-Mediated Protein-Drug Interactions in Patients With Moderate-to-Severe Plaque Psoriasis Receiving Subcutaneous Guselkumab. Clin Transl Sci. 2020 Nov;13(6):1217-1226. doi: 10.1111/cts.12807. Epub 2020 May 28.

    PubMed 32407591

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Guselkumab, Midazolam and Warfarin in people with Psoriasis, run by Janssen Research & Development, LLC at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) (time frame: Screening up to 96 hours on Day 1, 15 and 36). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02397382, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2017.

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