drugset / Trial / NCT01090570
Safety, Pharmacokinetic (PK), Pharmcodynamic (PD), and Drug-Drug Interaction of PLX3397 in Patients With Rheumatoid Arthritis Who Are Receiving Methotrexate
RandomizedParallel-groupTriple-blindTreatment
Summary
PLX3397 is a selective inhibitor of Fms and Kit activity. The objective of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interaction (DDI) of orally administered PLX3397 during 2 weeks of dosing in patients with rheumatoid arthritis (RA) who are on maintenance methotrexate. This study is planned to provide data to inform dose selection for a subsequent 12 week dose ranging study in RA.
Timeline
- Start
- 2010-05
- Primary completion
- 2010-12
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pexidartinib | Small molecule | 25 mg | Oral |
| Subject | Pexidartinib | Small molecule | 50 mg | Oral |
| Subject | Pexidartinib | Small molecule | 100 mg | Oral |
| Subject | Pexidartinib | Small molecule | 200 mg | Oral |
| Subject | Pexidartinib | Small molecule | 300 mg | Oral |