drugset / Trial / 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
NaSingle-groupOpen-labelBasic science
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.
Timeline
- Start
- 2012-10-11
- Primary completion
- 2013-10-19
- Completion
- 2013-10-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caffeine | Small molecule | 100 mg | Oral |
| Subject | Midazolam | Small molecule | 0.03 mg/kg | Oral |
| Subject | Omeprazole | Other / unclassified | 20 mg | Oral |
| Subject | Sirukumab | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | Vitamin K | Unknown | 10 mg | Oral |
| Subject | Warfarin | Small molecule | 10 mg | Oral |