Safety, Tolerance, Pharmacokinetics and Activity of HE3286 in Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HE3286
HE3286
HE3286
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring phase I, safety, tolerance, rheumatoid arthritis, pharmacokinetics, methotrexate, anti-inflammatory
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Arm Description
10 mg HE3286 (1 x 5 mg HE3286, BID)
20 mg HE3286 (2 x 5 mg HE3286 BID)
40 mg HE3286 (4 x 5 mg HE3286 BID)
Outcomes
Primary Outcome Measures
Safety and pharmacokinetics
Secondary Outcome Measures
To assess the potential activity of HE3286 to decrease inflammation via evaluation of inflammatory cytokine activity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00712114
Brief Title
Safety, Tolerance, Pharmacokinetics and Activity of HE3286 in Patients With Rheumatoid Arthritis
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Harbor Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
phase I, safety, tolerance, rheumatoid arthritis, pharmacokinetics, methotrexate, anti-inflammatory
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
10 mg HE3286 (1 x 5 mg HE3286, BID)
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
20 mg HE3286 (2 x 5 mg HE3286 BID)
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
40 mg HE3286 (4 x 5 mg HE3286 BID)
Intervention Type
Drug
Intervention Name(s)
HE3286
Other Intervention Name(s)
Triolex
Intervention Description
HE3286 will be administered orally. Dosing will be 10 mg per day for 29 days.
Intervention Type
Drug
Intervention Name(s)
HE3286
Other Intervention Name(s)
Triolex
Intervention Description
HE3286 will be administered orally. Dosing will be 20 mg per day for 29 days
Intervention Type
Drug
Intervention Name(s)
HE3286
Other Intervention Name(s)
Triolex
Intervention Description
HE3286 will be administered orally. Dosing will be 40 mg per day for 29 days
Primary Outcome Measure Information:
Title
Safety and pharmacokinetics
Time Frame
Duration of the study
Secondary Outcome Measure Information:
Title
To assess the potential activity of HE3286 to decrease inflammation via evaluation of inflammatory cytokine activity.
Time Frame
Duration of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dwight Stickney, MD
Organizational Affiliation
Hollis-Eden
Official's Role
Study Director
Facility Information:
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
12. IPD Sharing Statement
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Safety, Tolerance, Pharmacokinetics and Activity of HE3286 in Patients With Rheumatoid Arthritis
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