NCT00848939已完成1 期
An Evaluation of the Pharmacokinetics and Safety of Fixed and Escalating Doses of Oral Treprostinil Diethanolamine (UT-15C) Sustained Release Tablets in Patients With Systemic Sclerosis
United Therapeutics3 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2008年12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
- 28
- 试验地点
- 3
- 主要终点
- Cohort 1: treprostinil pharmacokinetics in patients with systemic sclerosis following single oral administration of a 1 mg treprostinil diethanolamine SR dose.
研究概览
简要总结
This study will assess the pharmacokinetic and safety profile of treprostinil following fixed and escalating doses of treprostinil diethanolamine SR tablets. Open-label, two-part study assessing the pharmacokinetics, safety, and tolerability of oral treprostinil diethanolamine SR. Cohort 1: single 1 mg treprostinil diethanolamine SR dose. Cohort 2: escalating doses of treprostinil diethanolamine SR up to a target dose of 4 mg BID.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject gives voluntary written informed consent to participate in the study.
- •Subject has been diagnosed with systemic sclerosis (SSc) as defined by American College of Rheumatology (ACR) criteria.
- •Males and females age greater than 18 years at time of Screening.
- •Presence of active digital ulcer OR history of digital ulcer occurring within past 6 months at time of Screening and poorly controlled Raynaud's phenomenon (as documented by patient report of 6-10 episodes per week).
- •Females of childbearing potential must be willing to use two forms of medically acceptable contraception (at least one barrier method) and have a negative pregnancy test at Screening, confirmed at Baseline if separate visits. Women who are surgically sterile or have been post-menopausal for at least 2 years are not considered to be of child-bearing potential.
- •Subject agrees to abstain from consuming grapefruit containing food or beverages for 3 days prior to Baseline and until discharge from the study.
- •Subject is able to communicate effectively with study personnel and be considered reliable, willing and cooperative in terms of compliance with the protocol requirements.
排除标准
- •Has diagnosis of pulmonary arterial hypertension and receiving approved or investigational therapies for PAH, including endothelin receptor antagonists, phosphodiesterase inhibitors, or prostacyclin analogues.
- •Body weight less than 40 kg at time of Screening, confirmed at Baseline.
- •The subject has a history of postural hypotension, unexplained syncope, a blood pressure that is less than 85 mmHg systolic or 50 mmHg diastolic at Screening or Baseline.
- •Hemoglobin concentration less than 75% of the lower limit of the normal range at time of Screening.
- •AST and/or ALT concentrations greater than 3 times upper limit of normal (ULN) at time of Screening.
- •Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
- •Intractable diarrhea, severe malabsorption, defined as greater than 15% unintentional loss of body weight in the last 6 months prior to Screening, or any severe organ failure (e.g., lung, kidney) or any life-threatening condition.
- •Pregnancy or breast-feeding.
- •Overlap with another connective tissue disease that could affect rest pain and hand function (e.g. diabetes mellitus, rheumatoid arthritis).
- •Sympathectomy of the upper limb performed within 12 months of Baseline.
- •Receipt of parenteral prostanoid treatment (epoprostenol, treprostinil sodium, or other prostacyclin analog) within the previous 3 months for conditions including PAH, rest pain and / or digital ulcers.
- •Treatment with gemfibrozil, glitazones, or cyclophosphamide within 1 week prior to Baseline.
- •Treatment with rifampin within 4 weeks prior to Baseline.
- •Local injection of botulinum toxin in an affected finger within 1 month prior to Baseline.
- •Received systemic antibiotics to treat infection of digital ulcers within 2 weeks prior to Baseline.
- •Treatment with phosphodiesterase inhibitors such as sildenafil, except for intermittent treatment of male erectile dysfunction.
- •Received an investigational product within 1 month preceding Screening.
- •Known hypersensitivity to oral treprostinil or any of the excipients.
- •Cigarette smoking at any level within the past 6 months prior to Screening.
- •Any condition that could prevent compliance with the protocol or adherence to therapy.
研究组 & 干预措施
treprostinil diethanolamine
Experimental
干预措施: treprostinil diethanolamine (Drug)
结局指标
主要结局
Cohort 1: treprostinil pharmacokinetics in patients with systemic sclerosis following single oral administration of a 1 mg treprostinil diethanolamine SR dose.
时间窗: pre-24hrs post dose
Cohort 2: treprostinil pharmacokinetics at dose levels of 2 mg BID and 4 mg BID, respectively, in patients with systemic sclerosis following repeated oral administration of treprostinil diethanolamine SR tablets
时间窗: 0-12 hrs post-dose
adverse event monitoring
时间窗: Cohort 1:Day 0 to Day 2; Cohort 2: Day 0 to Day 47
次要结局
- clinical laboratories(Cohort 1: Day 0 and Day 2; Cohort 2: Day 0 and Day 47)
- Cohort 2: Raynauds Phenomenon Visual Analoge Scale(7 weeks)
研究者
研究点 (3)
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