NCT00712114已完成1 期
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
Harbor Therapeutics0 个研究点目标入组 14 人开始时间: 2008年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 主要终点
- Safety and pharmacokinetics
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Cohort 1
Experimental
10 mg HE3286 (1 x 5 mg HE3286, BID)
干预措施: HE3286 (Drug)
Cohort 2
Experimental
20 mg HE3286 (2 x 5 mg HE3286 BID)
干预措施: HE3286 (Drug)
Cohort 3
Experimental
40 mg HE3286 (4 x 5 mg HE3286 BID)
干预措施: HE3286 (Drug)
结局指标
主要结局
Safety and pharmacokinetics
时间窗: Duration of the study
次要结局
- To assess the potential activity of HE3286 to decrease inflammation via evaluation of inflammatory cytokine activity.(Duration of study)
研究者
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