F901318 - A Two Part Study Designed to Evaluate the Single and Multiple Dose Pharmacokinetics of an Immediate Release Tablet Formulation of F901318
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pharmacokinetics
研究概览
简要总结
Single dose comparison of liquid and solid formulation, followed by study of effect of high fat breakfast.
Evaluation of multiple dose pharmacokinetics and tolerability
详细描述
The study will be split into 2 parts, Part 1, ( A and B), and Part 2.
Part 1A Part 1A of the study will be a single centre, open label, 2-way crossover in healthy male and female volunteers and will assess the relative bioavailability of a single 360 mg dose (as 3 x 120mg tablets) of F901318 IR tablet formulation in comparison to a 360 mg dose of an SDD suspension for oral dosing. It is planned that 10 volunteers will be enrolled to Part 1A of the study. These 10 subjects will continue into Part 1B of the study.
There will be a minimum washout of 10 days between doses provided to volunteers.
Following Part 1A there will be a two week period of interim analysis during which safety and pharmacokinetic data will be reviewed. In order to assess doses within the therapeutic range in Part 1B, a decision will be made using the available data, on whether the dose of F901318 IR tablet formulation should be altered. Dose will be altered by amending the number of units dosed.
Part 1B Following the dose decision meeting where data obtained in Part 1A of the study is reviewed, the selected dose of F901318 IR tablet formulation will be assessed in a further single centre, open label, 2-way crossover in healthy male and female volunteers. The selected dose will be administered in the fed (30 minutes following an FDA high fat meal) and fasted states in a randomised fashion. .
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be healthy males or females of any ethnic origin between 18 and 55 years of age and weighing between 50-100 kg (body mass index of 18.0-32.0 kg/m2 inclusive).
- •Females of child bearing potential must be established on a reliable form of contraception and have a negative pregnancy test at screening.
- •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 acceptable).
- •Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.
排除标准
- •Subjects who do not have suitable veins for multiple vene-punctures/cannulation as assessed by the investigator at screening
- •Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
- •Male or female subjects who are not willing to use appropriate contraception during the study and until 3 months after the last dose.
- •Subjects who have received any prescribed systemic or topical medication 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.
研究组 & 干预措施
F901318 SDD
Liquid formulation
干预措施: F901318 SDD (Drug)
F901318 IR
Solid formulation
干预措施: F901318 IR (Drug)
F901318 IR Fasting
Fasting solid formulation
干预措施: F901318 IR Fasting (Drug)
F901318 IR Fed
Fed solid formulation
干预措施: F901318 IR Fed (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: 120 hours
Area Under Concentration Time Curve
次要结局
- Treatment emergent adverse events(120 hours)