NCT04246762View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

November 16, 2021

Primary Completion Date

June 8, 2022

Study Completion Date

October 26, 2022

Conditions
Rheumatoid Arthritis
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

Trial Locations (2)

1618

Comac Medical Ltd, Sofia

MD2025

ICS ARENSIA Exploratory Medicine SRL, a daughter company of ARENSIA Exploratory Medicine GmbH,Republican Clinical Hospital, Chisinau

All Listed Sponsors
collaborator

IQVIA Pvt. Ltd

INDUSTRY

collaborator

Thermo Fisher Scientific FS

OTHER

lead

R-Pharm International, LLC

INDUSTRY

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 | Biotech Hunter | Biotech Hunter