Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Harbor Therapeutics
ClinicalTrials.gov Identifier:
NCT00712114
First received: July 6, 2008
Last updated: June 11, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: HE3286
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II, Open Label, Dose Ranging Study of the Safety, Tolerance, Pharmacokinetics and Potential Anti-Inflammatory Activity of HE3286 When Administered Orally for 29 Days to Patients With Rheumatoid Arthritis on a Stable Dose of Methotrexate

Resource links provided by NLM:


Further study details as provided by Harbor Therapeutics:

Primary Outcome Measures:
  • Safety and pharmacokinetics [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the potential activity of HE3286 to decrease inflammation via evaluation of inflammatory cytokine activity. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: July 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
10 mg HE3286 (1 x 5 mg HE3286, BID)
Drug: HE3286
HE3286 will be administered orally. Dosing will be 10 mg per day for 29 days.
Other Name: Triolex
Experimental: Cohort 2
20 mg HE3286 (2 x 5 mg HE3286 BID)
Drug: HE3286
HE3286 will be administered orally. Dosing will be 20 mg per day for 29 days
Other Name: Triolex
Experimental: Cohort 3
40 mg HE3286 (4 x 5 mg HE3286 BID)
Drug: HE3286
HE3286 will be administered orally. Dosing will be 40 mg per day for 29 days
Other Name: Triolex

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712114

Locations
United States, California
Beverly Hills, California, United States, 90211
Sponsors and Collaborators
Harbor Therapeutics
Investigators
Study Director: Dwight Stickney, MD Hollis-Eden
  More Information

No publications provided

Responsible Party: Nanette Onizuka-Handa/Sr. Vice President, Regulatory Affairs and Quality, Hollis-Eden Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00712114     History of Changes
Other Study ID Numbers: HE3286-0201
Study First Received: July 6, 2008
Last Updated: June 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Harbor Therapeutics:
phase I
safety
tolerance
rheumatoid arthritis
pharmacokinetics
methotrexate
anti-inflammatory

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014