A Phase 1 interventional study of Sirukumab and Midazolam in Arthritis, Rheumatoid, sponsored by Janssen Research & Development, LLC. Completed at 5 sites in 4 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-03-07.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Basic science
The main purpose of this study is to evaluate the potential effects of a single dose of sirukumab on the pharmacokinetics (what the body does to a drug) of study agents that are specific for cytochrome P450 (CYP) enzymes (CYP3A4, CYP2C9, CYP2C19, and CYP1A2) in patients with active rheumatoid arthritis (RA). This study will also assess the safety and tolerability of a single subcutaneous (SC, under the skin) dose of sirukumab in patients with active RA.
This is an open-label (all patients and study personnel will know the identity of the administered study agents), multi-center, drug-drug interaction study. Approximately 18 patients may be enrolled in this study, and there will be one treatment group. All patients will receive a single subcutaneous (SC) dose of sirukumab. Cytochrome P450 (CYP) enzyme-specific study agents (5-probe cocktail) will consist of oral doses of midazolam, warfarin/vitamin K, omeprazole, and caffeine administered on 4 separate occasions throughout the study. A blood sample for CYP genetic analysis (genotyping) will be collected during screening from all prospective patients to determine eligibility for the study. Participation in CYP genotyping prescreening is mandatory for all patients. The CYP genotyping blood sample will not be used for any additional genetic research and will be destroyed after completion of this study. The total duration of study participation will be approximately 12 weeks for all patients included in the study, including a screening visit up to 4 weeks prior to first study agent administration. Patients will have five in-patient periods, four consisting of 3 days and 2 nights each and one consisting of 2 days and 1 night. Patients safety will be monitored throughout the study, and there will be approximately 7 weeks of safety follow-up after sirukumab administration.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 12 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The 5-probe cocktail will consist of oral doses of midazolam, warfarin/vitamin K, omeprazole, and caffeine.
Drug: Sirukumab · Drug: Midazolam · Drug: Warfarin · Drug: Vitamin K · Drug: Omeprazole · Drug: Caffeine
Type=exact number, unit=mg, number=300, form=solution for injection, route=subcutaneous use, on Day 8
Type=exact number, unit=mg/kg, number 0.03, form=commercially available form, route=oral use, on Days 1, 15, 29, and 50
Type=exact number, unit=mg, number= 10, form=commercially available form, route=oral use, on Days 1, 15, 29, and 50
Type=exact number, unit=mg, number =10, form=commercially available form, route=oral use, on Days 1, 15, 29, and 50
Type=exact number, unit=mg, number=20, form=commercially available form, route=oral use, on Days 1, 15, 29, and 50
Type=exact number, unit=mg, number=100, form=commercially available form, route=oral use, on Days 1, 15, 29, and 50
Pharmacokinetics of midazolam, S-warfarin, omeprazole, and caffeine
Pharmacokinetic parameters will include the maximum observed plasma concentration (Cmax), time to reach the maximum observed plasma concentration (Tmax), area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration (AUClast), area under the plasma concentration-time curve from time 0 to 96 hours (AUC0-96h) (S-warfarin only), area under the plasma concentration versus time curve from time 0 to infinity with extrapolation of the terminal phase (AUCinf).
Time frame: Up to 54 days
Number of participants with adverse events
Time frame: Up to 12 weeks
Clinical laboratory assessments
Blood and urine tests
Time frame: Up to 12 weeks
Electrocardiograms (ECGs)
Time frame: Up to 12 weeks
Vital signs evaluations
Time frame: Up to 12 weeks
Physical examination
Time frame: Up to 12 weeks
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC