NCT02201849已完成1 期
A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral ALKS 8700 in Healthy Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Safety and tolerability will be measured by incidence of adverse events
研究概览
简要总结
This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a monomethyl fumerate (MMF) molecule.
详细描述
This study record was previously posted/updated by Alkermes, Inc. As of 29 Oct 2019, the sponsorship of the trial was transferred to Biogen along with responsibility for subsequent updates to the record.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Has a body-mass Index (BMI) >/=18.0 and </=32.0 kg/m2
- •Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration
- •Additional criteria may apply
排除标准
- •Is currently pregnant or breastfeeding
- •Has a lifetime history of menopausal hot flashes
- •Has a clinically significant medical condition
- •Has had a clinically significant illness in the 30 days prior to first study drug administration
- •Has had a serious infection (eg, pneumonia or septicemia) within the 3 months prior to study drug administration
- •Has had any vaccinations in the 4 weeks prior to inpatient admission
- •Has a lifetime history of diabetes
- •Additional criteria may apply
研究组 & 干预措施
Study Drug
Experimental
Oral capsules
干预措施: Study Drug (Drug)
Active Control
Active Comparator
Oral capsules
干预措施: Active Control (Drug)
Placebo
Placebo Comparator
Oral capsules
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability will be measured by incidence of adverse events
时间窗: up to 27 days
次要结局
- Maximum plasma concentration (Cmax)(up to 27 days)
- Time to attain Cmax (Tmax)(Up to 27 days)
- Area under the concentration-time curve from time 0 to infinity (AUCinf)(Up to 27 days)
- Area under the concentration-time curve from 0 to the last quantifiable time interval (AUClast)(Up to 27 days)
研究者
研究点 (1)
Loading locations...
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