A Phase 1, Open-label, Randomised, Cross Over Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects Following Single Doses
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Relative bioavailability of FDL169 and its metabolites with different formulations
研究概览
简要总结
This is a randomised, cross-over study comprised of 6 periods in healthy subjects.Subjects will receive Regimens A, B and C in a randomised crossover manner in the fed state, followed by Regimens D, E and F in a randomised crossover manner, in the fasted or fed state, as applicable.
详细描述
This is a single centre, randomised, cross-over study comprised of 6 periods in healthy males and females.Subjects will receive Regimens A, B and C in a randomised crossover manner in the fed state, followed by Regimens D, E and F in a randomised crossover manner, in the fasted or fed state, as applicable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Healthy male and non-pregnant, non-lactating female subjects
- •Aged 18 to 55 years
- •Body mass index of 18.0 to 32.0 kg/m2
- •Must agree to the use of an adequate method of contraception
排除标准
- •Subjects who have received any IMP in a clinical research study within the previous 3 months
- •History of any drug or alcohol abuse in the past 2 years
- •Current smokers and those who have smoked within the last 12 months.
- •Alkaline phosphatase, aspartate aminotransferase and/or alanine aminotransferase level >1.5 x upper limit of normal at screening
- •Abnormal renal function at screening
- •Clinically significant abnormal biochemistry, haematology, coagulation profile or urinalysis
- •Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- •History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or GI disease, neurological or psychiatric disorder.
- •Subjects with a history of gall stones or abdominal surgery eg cholecystectomy
- •Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- •Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedy (including known inhibitors or inducers of CYP3A4
研究组 & 干预措施
Regimen A
FDL169 200 mg reference tablet
干预措施: FDL169 (Drug)
Regimen B
FDL169 200 mg testing tablet 1
干预措施: FDL169 (Drug)
Regimen C
FDL169 200 mg testing tablet 2
干预措施: FDL169 (Drug)
Regimen D
FDL169 200 mg testing tablet 1 or 2 with high fat diet
干预措施: FDL169 (Drug)
Regimen E
FDL169 200 mg testing tablet 1 or 2, fasted
干预措施: FDL169 (Drug)
Regimen F
FDL169 200 mg testing tablet 1 or 2, with standard diet
干预措施: FDL169 (Drug)
结局指标
主要结局
Relative bioavailability of FDL169 and its metabolites with different formulations
时间窗: 17 weeks
To determine the relative bioavailability of FDL169 and its metabolites M1 and M3, following different tablet formulations compared to a reference tablet
次要结局
- Pharmacokinetic parameters, Tmax(17 weeks)
- Incidence of Treatment-Emergent Adverse Events(17 weeks)
- Pharmacokinetic parameters, Cmax(17 weeks)
- Pharmacokinetic parameters, AUC(17 weeks)