NCT01981005已完成1 期
A PHASE 1, SINGLE-CENTER, OPEN-LABEL STUDY INVESTIGATING THE EXCRETION BALANCE, PHARMACOKINETICS AND METABOLISM OF A SINGLE ORAL DOSE AND PHARMACOKINETICS OF AN INTRAVENOUS TRACER OF [14-C]-RO5424802 IN HEALTHY MALE SUBJECTS
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- Pharmacokinetics: Bioavailability (Area under the plasma concentration-time curve [AUC]) after administration of RO5424802
研究概览
简要总结
This non-randomized, single group, open-label study will investigate the mass balance, routes of elimination, pharmacokinetics, and metabolism of a single oral dose of RO5424802 and the pharmacokinetics of a 14C-labeled tracer in healthy volunteers
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male adults, 18 to 45 years of age, inclusive
- •Body mass index (BMI) from 18 to 32 kg/m2, inclusive
- •Willingness to use effective contraception as outlined in the protocol
- •Willingness to abstain from alcohol and xanthine-containing beverages or food (coffee, tea, cola, chocolate and "energy drinks") from 72 hours prior to the first dose until discharged
- •Willingness to avoid prolonged sun exposure and guard against sunburn during study & follow-up
排除标准
- •Clinically significant medical history or findings in physical examination, vital signs, or laboratory test results prior to study start
- •Positive screening tests for hepatitis B or C, HIV, alcohol, drugs of abuse, or tobacco
- •Regular smoking within 6 months prior to first dosing. Subjects should avoid smoky environments for at least 1 week prior to each cotinine screen
- •Excessive alcohol consumption
- •Use of any metabolic inducers (including herbals such as St. John's Wort) within 4 weeks or 5 half-lives (whichever is longer) before the first dose of study medication, including but not limited to: rifampin, rifabutin, glucocorticoids, carbamazepine, phenytoin and phenobarbital
- •Regular work with ionizing radiation or radioactive material
- •Subjects enrolled in a previous radiolabel study or who have received radiotherapy within 12 months prior to first dosing such that total radioactivity over a 12 month period would exceed an acceptable radiation burden > 0.1 mSv
- •Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column]), during work or participation in a medical trial in the previous year
- •Strenuous activity, sunbathing, or contact sports are not allowed from 4 days prior to entry into the clinical site until study follow-up
- •Participation in an investigational drug or device study within 60 days (or 6 months for biologic therapies) prior to first dosing
研究组 & 干预措施
RO5424802
Experimental
干预措施: RO5424802 (Drug)
结局指标
主要结局
Pharmacokinetics: Bioavailability (Area under the plasma concentration-time curve [AUC]) after administration of RO5424802
时间窗: Days 1 to 25
Elimination: Amount of drug excreted in urine/feces over the study period
时间窗: Days 11 to 15
次要结局
- Safety: Incidence of adverse events(Days 1 to 25)
- Pharmacokinetics: Metabolite identification in plasma, urine, and feces.(Days 11 to 25)
研究者
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