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

NCT ID: NCT00712114

Last Updated: 2011-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-07-31

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 orally for 29 days to patients with rheumatoid arthritis that are taking a stable dose of methotrexate.

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 (one of three open label doses) in addition to their current stable dose of methotrexate. Safety (via monitoring of vital signs, physical examination changes, ECG results, laboratory results, and adverse events), pharmacokinetics profiles (of HE3286 and methotrexate) and anti-inflammatory activity will be assessed over a treatment period of 29 days.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

10 mg HE3286 (1 x 5 mg HE3286, BID)

Group Type: EXPERIMENTAL

HE3286

Intervention Type: DRUG

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

Cohort 2

20 mg HE3286 (2 x 5 mg HE3286 BID)

Group Type: EXPERIMENTAL

HE3286

Intervention Type: DRUG

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

Cohort 3

40 mg HE3286 (4 x 5 mg HE3286 BID)

Group Type: EXPERIMENTAL

HE3286

Intervention Type: DRUG

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

Interventions

HE3286

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

Intervention Type: DRUG

HE3286

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

Intervention Type: DRUG

HE3286

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

Intervention Type: DRUG

Other Intervention Names

Triolex; Triolex; Triolex

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harbor Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Hollis-Eden Pharmaceuticals

Principal Investigators

Dwight Stickney, MD

Role: STUDY_DIRECTOR

Hollis-Eden

Locations

Beverly Hills, California, United States

Countries

United States

Other Identifiers

HE3286-0201

Identifier Type: -

Identifier Source: org_study_id