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

Summary

Participation Requirements

Description

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 this study is to examine whether olokizumab alters metabolism of following substrates selective for specif...

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 this study is to examine whether olokizumab alters metabolism of following substrates selective for specific CYP450 activity: caffeine (CYP1A2), S warfarin (CYP2C9), omeprazole (CYP2C19), and midazolam (CYP3A4) in patients with RA. After 35-day screening period, 15 subjects who meet the study eligibility criteria will be administered a cocktail of 4 substrates alone during 7-day PK-sampling Period 1. A single subcutaneous dose of 128 mg OKZ will be administered (Period 2) approximately 2 weeks prior to the second administration of the cocktail in 7-day PK-sampling Period 3. After completion of the Period 3 patients will be followed for 19 weeks for safety evaluations. The duration of the study will be approximately 6.5 months. Approximately 3 Investigators and study centers are expected to participate in this study. 12 evaluable subjects will be required to complete the study. It is estimated that 15 subjects who meet the study eligibility criteria will need be dosed in order to achieve this number. However, if necessary, additional subjects may be dosed to obtain the 12 evaluable subjects required.

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