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

NCT00712114 | Completed Phase 1

• 1 other identifier: HE3286-0201
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

phase I; safety; tolerance; rheumatoid arthritis; pharmacokinetics; methotrexate; anti-inflammatory

Outcome Measures

Primary Outcomes (1)

• Safety and pharmacokinetics

  Duration of the study

Secondary Outcomes (1)

• To assess the potential activity of HE3286 to decrease inflammation via evaluation of inflammatory cytokine activity.

  Duration of study

Study Arms (3)

Cohort 1

EXPERIMENTAL

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

Drug: HE3286

Cohort 2

EXPERIMENTAL

20 mg HE3286 (2 x 5 mg HE3286 BID)

Drug: HE3286

Cohort 3

EXPERIMENTAL

40 mg HE3286 (4 x 5 mg HE3286 BID)

Drug: HE3286

Interventions

HE3286 DRUG

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

Also known as: Triolex

Cohort 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Harbor Therapeutics: lead

Study Sites (1)

Unknown Facility

Beverly Hills, California, 90211, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

17-ethynyl-5-androstene-3, 7, 17-triol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Dwight Stickney, MD

  Hollis-Eden

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 6, 2008
• First Posted: July 9, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: June 14, 2011

Record last verified: 2011-06

Locations

US (1)