NL-OMON41185已完成不适用
An open-label, fixed-sequence study in healthy male subjects to assess the effect of single and multiple-doses of JNJ-54861911 on the components of a Drug *Cocktail* representative for CYP3A4, CYP2C9, and CYP1A2 substrates. - 54861911ALZ1010 (CS0221)
QPS Netherlands B.V.0 个研究点目标入组 16 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
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. Subject must be a man, 18 to 55 years of age, inclusive.
- •2. Subjects must have a body mass index (BMI) between 18 and 30
- •kg/m2, inclusive (BMI = weight/height²) and a body weight of not less
- •than 50 kg.
- •3. Subject must be healthy on the basis of physical examination, medical
- •history, vital signs, and 12-lead ECG performed at screening or
- •admission (up to Day 1 predose). Minor deviations in ECG, which are not
- •considered to be of clinical significance to the investigator, are
- •acceptable.
排除标准
- •1. Subject has any clinically significant abnormal findings in physical
- •examination, vital signs or 12-lead ECG (incl. QTcF>450msec, Left
- •Bundle Branch Block, AV Block second degree or higher, permanent
- •pacemaker or implantable cardioverter defibrillator (ICD)) at screening
- •or admission (up to Day 1 predose), which in the opinion of the
- •investigator are not appropriate and reasonable for the population under
- •2. Subject has a history of or current liver or renal insufficiency; closedangle glaucoma, significant cardiac, vascular, pulmonary,
- •gastrointestinal, endocrine (e.g. thyroid disease, diabetis mellitus),
- •neurologic, hematologic, rheumatologic, psychiatric, or metabolic
- •disturbances.
- •3. Subject has a history of epilepsy or fits or unexplained black-outs
- •other than vasovagal collapse.
- •4. Subject has a known history of glucose-6-phopshate dehydrogenase
- •deficiency (G6PD) deficiency (favism)
- •5. Subject has known allergies, hypersensitivity, or intolerance to JNJ-54861911 or its excipients (refer to IB), sulfonamides, midazolam,
- •caffeine or tolbutamide.
- •6. Subject has contraindications to the use of caffeine, midazolam or
- •tolbutamide per local prescribing information.
- •7. Subject has had major surgery, (e.g., requiring general anesthesia)
- •within 8 weeks before screening, or will not have fully recovered from
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