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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

NCT04246762 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-08-15

Study results available
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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).

Conditions

Interventions

DRUG

Olokizumab

Sterile solution for subcutaneous (SC) injection, 128 mg (0.8 mL injection)

DRUG

Omeprazole

Tablets, 20 mg, oral

DRUG

Caffeine

Tablets, 100 mg, oral

DRUG

Warfarin+ Vitamin K

Warfarin -Tablets 10 mg (containing 5 mg S-warfarin), oral. Vitamin K - solution for intravenous injection, 10 mg/mL ampoule, orally.

DRUG

Midazolam

Syrup, 2 mg/mL, oral

Sponsors & Collaborators

  • IQVIA Pvt. Ltd

    collaborator INDUSTRY

  • Thermo Fisher Scientific FS

    collaborator OTHER

  • R-Pharm International, LLC

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · Chief Medical Officer, R-Pharm

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-16
Primary Completion
2022-06-08
Completion
2022-10-26
FDA Drug
Yes

Countries

  • Bulgaria
  • Moldova

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04246762 on ClinicalTrials.gov