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
NCT ID: NCT02397382
Last Updated: 2017-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2015-06-18
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Guselkumab
Guselkumab will be administered as a single dose of 200 milligram (mg) by subcutaneous injection (2\*100 mg) on Day 8.
Midazolam
Midazolam will be administered orally as probe cocktail containing 0.03 mg per kilogram (kg) once on Day 1, 15 and 36.
Warfarin
Warfarin will be administered orally as probe cocktail containing 10 mg once on Day 1, 15 and 36.
Omeprazole
Omeprazole will be administered orally as probe cocktail containing 20 mg once on Day 1, 15 and 36.
Dextromethorphan
Dextromethorphan will be administered orally as probe cocktail containing 30 mg once on Day 1, 15 and 36.
Caffeine
Caffeine will be administered orally as probe cocktail containing 100 mg once on Day 1, 15 and 36.
Interventions
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Guselkumab
Guselkumab will be administered as a single dose of 200 milligram (mg) by subcutaneous injection (2\*100 mg) on Day 8.
Midazolam
Midazolam will be administered orally as probe cocktail containing 0.03 mg per kilogram (kg) once on Day 1, 15 and 36.
Warfarin
Warfarin will be administered orally as probe cocktail containing 10 mg once on Day 1, 15 and 36.
Omeprazole
Omeprazole will be administered orally as probe cocktail containing 20 mg once on Day 1, 15 and 36.
Dextromethorphan
Dextromethorphan will be administered orally as probe cocktail containing 30 mg once on Day 1, 15 and 36.
Caffeine
Caffeine will be administered orally as probe cocktail containing 100 mg once on Day 1, 15 and 36.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
65 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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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
Countries
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References
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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.
Related Links
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A Phase I, 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
Other Identifiers
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CNTO1959PSO1003
Identifier Type: OTHER
Identifier Source: secondary_id
CR106796
Identifier Type: -
Identifier Source: org_study_id