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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harbor Therapeutics
• Treatments: Anti-Inflammatory Agents; Dehydroepiandrosterone; Methotrexate

Criteria

Main Inclusion Criteria:

• Male or female patient 18-75 years of age

• Patient with stable or active disease on a stable dose of methotrexate for at least 30 days prior to Day 1

• Patient has normal thyroid stimulating hormone (TSH) levels with or without thyroid replacement therapy

• Patient is willing to abstain from consuming grapefruit containing products from 24 hours prior to dosing until the end of the study as it may affect the pharmacokinetic measurements

• Patient has not experienced renal or liver disease by history and/or based on laboratory results

• Patient has not experienced acute cardiac disease within 6 months prior to Screening

• Patient must provide voluntary, written, informed consent prior to screening evaluations and be able to follow verbal and written instructions.

Main Exclusion Criteria:

• Functional status class IV according to The American College of Rheumatology (ACR) criteria

• Patient who has a history of clinically significant cardiovascular disease (including coronary artery disease), clinically significant hepatic, respiratory or renal abnormalities, or clinically significant endocrine disorders (including diabetes)

• Patient with active Tuberculosis (TB) or evidence of latent TB without previous adequate therapy

• Systemic autoimmune disorder (including, but not limited to, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or any overlap syndrome)

• Inflammatory joint disease other than RA

• Patient who has received any of the following immunosuppressive drugs:

• Etanercept within 1 month of Day 1;

• Abatacept, adalimumab, infliximab, leflunomide, imuran, cyclosporin, anakinra, sulfasalazine, bextra, celebrex or gold within 2 months of Day 1 or for biological agents 6 half lives, whichever is greater;

• Rituximab within 1 year of Day 1

• Patient that is bed or wheelchair bound

• Patients taking prednisone within 2 weeks prior to Screening

• Patient requiring or receiving any of the following within thirty (30) days prior to the screening visit: interleukins, steroids (i.e., anabolic steroids, glucocorticoids), hormone replacement therapy (except stable low-dose HRT for at least 6-months prior to screening), birth control pills, anti-cancer chemotherapeutic agents (except methotrexate), metabolic inhibitors (except methotrexate), concomitant medications that prolong the QT/QTc interval

• Patient who has any clinically significant abnormalities in laboratory results at Screening