drugset / Trial / NCT04246762
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
Phase 1
Completed
17 enrolled
R-Pharm International, LLC
IQVIA Pvt. Ltd · collabThermo Fisher Scientific FS · collab
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2021-11-16
- Primary completion
- 2022-06-08
- Completion
- 2022-10-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caffeine | Small molecule | 100 mg | Oral |
| Subject | Midazolam | Small molecule | 2 mg/ml | Oral |
| Subject | Olokizumab | Monoclonal antibody | 128 mg | Subcutaneous |
| Subject | Omeprazole | Other / unclassified | 20 mg | Oral |
| Subject | Warfarin | Small molecule | 10 mg | Oral |
| Background | Vitamin K | Unknown | 10 mg/ml | Oral |