A Phase I, Open Label Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of Varying Oral Dosing Regimens for F901318
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Incidence of treatment emergent adverse events
研究概览
简要总结
A Phase I, open label study evaluating safety, tolerability and pharmacokinetics of F901318 in healthy subjects following up to 28 days dosing, where F901318 is given orally . The effect of food upon the pharmacokinetics of F901318 and the effect of F901318 upon the pharmacokinetics of midazolam will also be assessed.
详细描述
Each cohort will comprise 12 healthy subjects and cohorts A1 (A2), B1 and B2 will be conducted in a sequential manner such that the dose level can be optimised upon review of emerging safety, tolerability and PK data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
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
- •Subjects will be males or females of any ethnic origin between 18 and 55 years of age, weighing between 60 and 100 kg, with a body mass index (BMI) between 18 and 30 kg/m
- •Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (congenital non-haemolytic hyperbilirubinaemia is not acceptable)
- •Male subjects and female subjects of childbearing potential must agree to use appropriate contraception from screening, during the study and for 3 months after the last dose of study drug
排除标准
- •Female subjects who are pregnant or lactating.
- •Subjects who have received any prescribed systemic or topical medication (other than hormonal contraception or hormone replacement therapy) within 14 days of the dose administration unless in the opinion of the Investigator and the medical monitor the medication will not interfere with the study procedures or compromise safety.
- •Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the dose administration (with the exception of vitamin/mineral supplements) unless in the opinion of the Investigator and the medical monitor the medication will not interfere with the study procedures or compromise safety.
- •Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the dose administration unless in the opinion of the Investigator and the medical monitor the medication will not interfere with the study procedures or compromise safety.
研究组 & 干预措施
A1; F901318 (10 days)
F901318 : 10 days dosing orally
干预措施: F901318 (Drug)
A2; F901318
F901318 : 10 days dosing orally, alternative dosing regimen
干预措施: F901318 (Drug)
A3; F901318
F901318 : 10 days dosing orally, alternative dosing regimen
干预措施: F901318 (Drug)
A4; F901318
F901318 : 10 days dosing orally, alternative dosing regimen
干预措施: F901318 (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events
时间窗: 18 days
safety and tolerability
次要结局
- maximum plasma concentration (Cmax) for F901318(11 days)
- minimum plasma concentration (Cmin) for F901318(11 days)
- Area under the curve (AUC) 0-tau for F901318(11 days)