drugset / Trial / NCT01090570

Safety, Pharmacokinetic (PK), Pharmcodynamic (PD), and Drug-Drug Interaction of PLX3397 in Patients With Rheumatoid Arthritis Who Are Receiving Methotrexate

NCT01090570

Phase 1 Withdrawn Plexxikon
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

EvaluationDrugModalityDoseRoute
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

Indications