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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

NCT01636557 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-03-07

No results posted yet for this study

Summary

The main purpose of this study is to evaluate the potential effects of a single dose of sirukumab on the pharmacokinetics (what the body does to a drug) of study agents that are specific for cytochrome P450 (CYP) enzymes (CYP3A4, CYP2C9, CYP2C19, and CYP1A2) in patients with active rheumatoid arthritis (RA). This study will also assess the safety and tolerability of a single subcutaneous (SC, under the skin) dose of sirukumab in patients with active RA.

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

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-10-11
Primary Completion
2013-10-19
Completion
2013-10-19

Countries

  • Germany
  • Moldova
  • South Africa
  • South Korea

Study Locations

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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 NCT01636557 on ClinicalTrials.gov