临床试验/NCT00418756

NCT00418756已完成1 期

A Phase I Open-label, Two Period, Single Center Study to Assess the Effect of 600 mg Daily Oral Dose of Rifampin (CYP3A4 Inducer) on the Pharmacokinetics of a Single 400 mg Oral Dose of Nilotinib in Healthy Subjects

Novartis Pharmaceuticals0 个研究点目标入组 12 人开始时间: 2006年10月最近更新: 2010年3月19日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Novartis Pharmaceuticals
入组人数: 12
主要终点: To evaluate the effects of 600 mg rifampin on the pharmacokinetics (PK) of a single 400mg (2 x 200mg capsules) oral dose of AMN107

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study will evaluate the effect of 600 mg daily oral dose of rifampin (CYP3A4 inducer) on the pharmacokinetics of a single 400 mg oral dose of nilotinib in healthy subjects

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 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy adult male (18 - 55 yrs) and sterile or post menopausal female subjects:
•Body weight must be ≥50 kg and <100 kg, with a body mass index (BMI) >18 but <33.

排除标准

•Female who is pregnant, test positive for a serum pregnancy test or currently breast feeding.
•Contraindication to receiving nilotinib or rifampin.
•Smokers or use of tobacco products or products containing nicotine in the last 30 days
•A past medical history of clinically significant Electrocardiogram abnormalities, or a history/family history of long QT-interval syndrome.
•Other protocol-defined inclusion/exclusion may apply.

研究组 & 干预措施

Rifampin + nilotinib

Experimental

干预措施: Nilotinib (Drug)

结局指标

主要结局

To evaluate the effects of 600 mg rifampin on the pharmacokinetics (PK) of a single 400mg (2 x 200mg capsules) oral dose of AMN107

时间窗: at pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose after AMN107 administration on Days 1 and 16.

次要结局

To assess the safety and tolerability of a single 400mg (2x200mg capsules) oral dose of AMN107 given alone and concomitantly with 600mg rifampin
To determine the ratio of 6ß - hydroxylcortisol to cortisol in urine as an in-vivomarker of CYP3A4 induction with rifampin treatment4.(on Days -1, 11, 15 and 19)

研究者

发起方

Novartis Pharmaceuticals

申办方类型

Industry

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