At a glance
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A Phase 1, Open-label, Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2, CYP2C9, CYP2C19, and CYP3A4
In Brief
A Phase 1 clinical trial evaluating Olokizumab, Omeprazole, and 3 other interventions for Rheumatoid Arthritis. Completed, enrolled 17 participants across 2 sites in 2 countries.
Detailed Summary
Olokizumab (OKZ) has been shown to reverse the inhibitory effect of IL-6 on the activity of Cytochrome P450 (CYP450) isozymes CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A4/5 in vitro. The goal of the study was to assess the effect of OKZ on the pharmacokinetics (PK) of the CYP450 probe substrates, caffeine (CYP1A2), S-warfarin (CYP2C9), omeprazole (CYP2C19), and midazolam (CYP3A4) in subjects with rheumatoid arthritis (RA).
Study Details
Timeline
Interventions
Sterile solution for subcutaneous (SC) injection, 128 mg (0.8 mL injection)
Tablets, 20 mg, oral
Tablets, 100 mg, oral
Warfarin -Tablets 10 mg (containing 5 mg S-warfarin), oral. Vitamin K - solution for intravenous injection, 10 mg/mL ampoule, orally.
Syrup, 2 mg/mL, oral