Status:
COMPLETED
Safety, Tolerance, Pharmacokinetics and Activity of HE3286 in Patients With Rheumatoid Arthritis
Lead Sponsor:
Harbor Therapeutics
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 oral...
Detailed Description
This is a Phase I/II, open label, dose ranging study of the safety, tolerance, and anti-inflammatory activity of HE3286 in patients with rheumatoid arthritis. Patients will receive study treatment (on...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00712114
Start Date
July 1 2008
End Date
July 1 2009
Last Update
June 14 2011
Active Locations (1)
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1
Beverly Hills, California, United States, 90211