Safety, Tolerance, Pharmacokinetics and Activity of HE3286 in Patients With Rheumatoid Arthritis

NCT00712114 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2011-06-14

No results posted yet for this study

Summary

The purpose of this pilot, exploratory study is to evaluate the safety, tolerance, pharmacokinetics and potential anti-inflammatory activity of an investigational agent, HE3286, when administered orally for 29 days to patients with rheumatoid arthritis that are taking a stable dose of methotrexate.

Conditions

Interventions

DRUG

HE3286

HE3286 will be administered orally. Dosing will be 10 mg per day for 29 days.

DRUG

HE3286

HE3286 will be administered orally. Dosing will be 20 mg per day for 29 days

DRUG

HE3286

HE3286 will be administered orally. Dosing will be 40 mg per day for 29 days

Sponsors & Collaborators

  • Harbor Therapeutics

    lead INDUSTRY

Principal Investigators

  • Dwight Stickney, MD · Hollis-Eden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Entities

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 NCT00712114 on ClinicalTrials.gov