临床试验/NCT01365403

NCT01365403已完成1 期

A SINGLE CENTER, OPEN LABEL, FIXED SEQUENCE, TWO-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSE CARBAMAZEPINE ON SINGLE DOSE PHARMACOKINETICS OF RO4917838 IN HEALTHY MALE VOLUNTEERS

Hoffmann-La Roche0 个研究点目标入组 16 人开始时间: 2011年4月最近更新: 2016年11月2日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Hoffmann-La Roche
入组人数: 16
主要终点: Area under the concentraion-time curve/maximum concentration (AUC/Cmax) of single dose RO4917838 with multiple dose carbamazepine administration

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 open-label, fixed sequence, two-period study will assess the effect of multiple dose carbamazepine on the single dose pharmacokinetics of RO4917838. Subjects will receive a single oral dose of RO4917838 on Day 1 of the 12-day study period 1 and, after a washout of 3-6 weeks, in study period 2 carbamazepine orally daily on Days 1-24 with a single oral dose of RO4917838 on Day 16.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Adult healthy male volunteers, 18-65 years of age inclusive
•Body mass index (BMI) 18-30 kg/m2 inclusive

排除标准

•History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator
•History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic or psychiatric disease, or cancer
•Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator
•Native Asians or subjects with Asian racial origin

研究组 & 干预措施

Single Arm

Experimental

干预措施: RO4917838 (Drug)

Single Arm

Experimental

干预措施: carbamazepine (Drug)

结局指标

主要结局

Area under the concentraion-time curve/maximum concentration (AUC/Cmax) of single dose RO4917838 with multiple dose carbamazepine administration

时间窗: approximately 4 weeks

次要结局

Safety: Incidence of adverse events(up to 13 weeks)

研究者

发起方

Hoffmann-La Roche

申办方类型

Industry

责任方

Sponsor

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