NCT01329991

Phase 1b Study of PLX5622 in Rheumatoid Arthritis Patients Who Are Receiving Methotrexate

A Phase 1b Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Drug-Drug Interaction of PLX5622 in Patients With Rheumatoid Arthritis Who Are Receiving Methotrexate

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Plexxikon · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PLX115-02 is a phase 1b study to assess how the study drug, PLX5622: 1. affects the body, 2. how the body affects PLX5622 3. the interaction of PLX5622 with Methotrexate and 4. the safety of PLX5622 in rheumatoid arthritis patients taking Methotrexate

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	PLX5622	PLX5622 drug substance is an achiral,small molecule Fms kinase inhibitor. The drug product is available in capsule form, to be taken orally, in a dosage strength of 100 mg with matching placebo
DRUG	Placebo	Matching placebo for PLX5622

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-04-06
• Last updated: 2012-04-12

Locations

4 sites across 1 country: United States