Overview

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

Status:
Recruiting

Trial end date:
2022-10-01

Target enrollment:

Participant gender:

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 is 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).

Phase:

Phase 1

Details

Lead Sponsor:

R-Pharm
R-Pharm International, LLC

Collaborators:

IQVIA RDS Ireland Ltd
Thermo Fisher Scientific

Treatments:

Caffeine
Midazolam
Omeprazole
Vitamin K
Vitamins
Warfarin