NCT01636557View on ClinicalTrials.gov

A Study to Evaluate the Effect of a Single Dose of CNTO 136 (Sirukumab) on CYP450 Enzyme Activities After Subcutaneous Administration in Patients With Rheumatoid Arthritis

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

October 11, 2012

Primary Completion Date

October 19, 2013

Study Completion Date

October 19, 2013

Conditions
Arthritis, Rheumatoid
Interventions
DRUG

Sirukumab

Type=exact number, unit=mg, number=300, form=solution for injection, route=subcutaneous use, on Day 8

DRUG

Midazolam

Type=exact number, unit=mg/kg, number 0.03, form=commercially available form, route=oral use, on Days 1, 15, 29, and 50

DRUG

Warfarin

Type=exact number, unit=mg, number= 10, form=commercially available form, route=oral use, on Days 1, 15, 29, and 50

DRUG

Vitamin K

Type=exact number, unit=mg, number =10, form=commercially available form, route=oral use, on Days 1, 15, 29, and 50

DRUG

Omeprazole

Type=exact number, unit=mg, number=20, form=commercially available form, route=oral use, on Days 1, 15, 29, and 50

DRUG

Caffeine

Type=exact number, unit=mg, number=100, form=commercially available form, route=oral use, on Days 1, 15, 29, and 50

Trial Locations (5)

Unknown

Berlin

Munich

Chisinau

Bloemfontein

Seoul

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01636557 - A Study to Evaluate the Effect of a Single Dose of CNTO 136 (Sirukumab) on CYP450 Enzyme Activities After Subcutaneous Administration in Patients With Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter