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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959PSO1003 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guselkumab and Cytochrome P450 Probe Cocktail | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab | Drug | Guselkumab will be administered as a single dose of 200 milligram (mg) by subcutaneous injection (2*100 mg) on Day 8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | 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) | 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]) | 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]) | 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 | The observed serum concentration of Guselkumab. | Pre-dose on Day 8 and up to Day 92 |
| Number of Participants with antibody to CNTO1959 | The frequency of anti-CNTO1959 antibodies. | Pre-dose on Day 8 and up to Day 92 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 92 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anniston | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32407591 | Derived | 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. |
| Label | URL |
|---|---|
| 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 | View source |
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| Midazolam | Drug | Midazolam will be administered orally as probe cocktail containing 0.03 mg per kilogram (kg) once on Day 1, 15 and 36. |
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| Warfarin | Drug | Warfarin will be administered orally as probe cocktail containing 10 mg once on Day 1, 15 and 36. |
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| Omeprazole | Drug | Omeprazole will be administered orally as probe cocktail containing 20 mg once on Day 1, 15 and 36. |
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| Dextromethorphan | Drug | Dextromethorphan will be administered orally as probe cocktail containing 30 mg once on Day 1, 15 and 36. |
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| Caffeine | Drug | Caffeine will be administered orally as probe cocktail containing 100 mg once on Day 1, 15 and 36. |
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| 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 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000588857 | guselkumab |
| D008874 | Midazolam |
| D014859 | Warfarin |
| D009853 | Omeprazole |
| D003915 | Dextromethorphan |
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
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