NCT02310048已完成1 期
A Randomised, Open-Label, Single-Dose, Parallel Group Study to Assess the Comparative Oral Bioavailability of Two Capsule Formulations of MT-1303 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
- 34
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve(AUC) .
研究概览
简要总结
The purpose of this study is to assess the comparative oral bioavailability of a Formulation B versus the Formulation A of MT-1303.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Caucasian males aged 18 to 55 years at Screening.
- •Healthy and free from clinically significant illness or disease as determined by medical history, physical examination, laboratory, and other tests at Screening and Day -
- •A body weight of ≥60 kilograms (kg) and BMI ranging from 18 to 30 kg/m2 at Screening or Day -1.
排除标准
- •Presence or history of severe adverse reaction or allergy to any medicinal product or relevant excipient that is of clinical significance.
- •Participated in more than three clinical studies of a new chemical entity in the previous year or participated in a clinical study of any IMP within 12 weeks or five half-lives of the IMP before the administration of the IMP in this clinical study.
- •Clinically relevant abnormal medical history, physical findings, or laboratory values at Screening or Day -1 that could interfere with the objectives of the study or the safety of the subject, as judged by the Investigator.
- •Previous medical history of tuberculosis or in the opinion of the Investigator a recurrent medical history of cold sores, pharyngitis, urinary tract infection, diarrhoea/dysentery, chest infections, or fungal infection.
- •Subjects who have received any prescribed systemic or topical medication within 14 days prior to administration of the IMP(Day 1) unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study procedures or compromise safety. Slow release medicinal formulations considered to still be active within 14 days prior to the first dose administration will also be excluded unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study procedures or compromise safety.
研究组 & 干预措施
MT-1303-FormA
Experimental
MT-1303, Capsule Formulation A
干预措施: MT-1303-FormA (Drug)
MT-1303-FormB
Experimental
MT-1303, Capsule Formulation B
干预措施: MT-1303-FormB (Drug)
结局指标
主要结局
Area under the concentration-time curve(AUC) .
时间窗: up to 6 weeks
次要结局
- Half-life(t1/2.) of MT-1303(up to 6 weeks)
- Time to reach peak concentration (Tmax) of MT-1303(up to 6 weeks)
- Peak drug concentration (Cmax) of MT-1303(up to 6 weeks)
研究者
研究点 (1)
Loading locations...
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