NL-OMON50115已完成不适用
A phase 1 trial to assess P-gp mediated drug interactions with ASTX660 in healthy volunteers - ASTX660 P-gp interaction study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Sex assigned at birth : male or female; females of nonchildbearing
- •potential, or postmenopausal.
- •2. Age : 18 to 65 years, inclusive, at screening.
- •3. Body mass index (BMI) : 18.0 to 32.0 kg/m2, inclusive, at screening.
- •4. Weight : >=50 kg.
- •5. Status : healthy subjects.
排除标准
- •1. Employee of PRA or the Sponsor.
- •2. History of relevant drug and/or food allergies.
- •3. History of alcohol abuse or drug addiction (including soft drugs like
- •cannabis products) within 2 years prior to screening in the current study.
- •4. History or presence of atrioventricular block (any degree) or sick sinus
- •5. Subjects with increased cardiac risk evaluation based on the following
- •Smoking (no more than 2 packs of cigarettes) in the last 6 months prior to
- •admission, including use of nicotine-containing products (eg, snuff, nicotine
- •patch, nicotine chewing gum, mock cigarettes, e-cigarettes, or inhalers), or
- •positive cotinine test at screening (ie, cotinine value >500 ng/mL will be
- •Subjects with first-degree family history of ischemic cardiac event at a
- •young age (male <55; female <65 years).
- •Subjects with family history of arrhythmia, sudden unexplained death at a
- •young age (before 40 years) in a first-degree relative, or long QT syndrome,
- •Torsades de Pointes (TdP), or a personal history of repeated or frequent
- •syncope or vasovagal episodes, or treatment for high blood pressure.
- •History or presence of resuscitated arrest possibily due to TdP;
- •hypertension, angina, or severe peripheral arterial circulatory disorders.
- •History or presence of risk factors for TdP (eg, congenital deafness, heart
- •failure, cardiomyopathy).
- •History or presence of myocardial infarction, pulmonary congestion, cardiac
- •arrhythmia, or prolonged QT interval, or conduction abnormalities.
- •History or presence of concomitant medications-induced QTc prolongation
- •within 30 days prior to screening.
- •History or presence of hypokalemia, hypomagnesemia, or hypocalcemia.
- •See the protocol for the complete overview
研究者
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