NCT01698333已完成2 期
An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Twice Daily 122-0551 in Subjects With Plaque Psoriasis Receiving Two Weeks of Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Hypothalamic-Pituitary-Adrenal (HPA) Axis Response
研究概览
简要总结
Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is designed to determine the adrenal effects of the investigational formulation of 122-0551 and characterize the steady state pharmacokinetics of the formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a clinical diagnosis of stable plaque psoriasis
排除标准
- •Subject has spontaneously improving or rapidly deteriorating plaque psoriasis
- •Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis
- •Subject has used any phototherapy, photo-chemotherapy or systemic psoriasis therapy within 30 days prior to initiation of treatment
- •Subject has used systemic corticosteroids or topical, inhaled, intranasal corticosteroids within 30 days and 14 days, respectively, prior to study screening
- •Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to initiation of treatment
- •Subject has used topical psoriatic therapy including tar, anthralin, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to initiation of treatment
- •Subject has used emollients/moisturizers on areas to be treated within one day prior to initiation of treatment
- •Subject is currently using lithium or Plaquenil (hydroxychloroquine)
- •Subject is currently using a beta-blocking medication (e.g., propranolol) or angiotensin converting enzyme (ACE) inhibitors (e.g., lisinopril) at a dose that has not been stabilized
- •Subject is pregnant, nursing or planning a pregnancy during the study period
- •Subject is currently enrolled in an investigational drug, biologic or device study
- •Subject has received an investigational drug, biologic or an investigational device within 30 days prior to study start
- •Subject has been previously enrolled in this study and treated with the test article
- •Subject has an irregular sleep schedule or works night shifts
研究组 & 干预措施
122-0551
Experimental
干预措施: 122-0551 (Drug)
结局指标
主要结局
Hypothalamic-Pituitary-Adrenal (HPA) Axis Response
时间窗: Day 15
HPA axis response to stimulation by cosyntropin, dichotomized to "normal" and "abnormal". Laboratory evidence of abnormal HPA axis response is defined as a 30-minute post-stimulation serum cortisol level that is ≤ 18 μg/dL at the end of study.
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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