Comparison of the Relative Oral Bioavailability of GKT137831 Formulated in Capsules or in Tablets and Evaluation of the Potential Impact of Concomitant Food Intake on the Relative Bioavailability of GKT137831 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Oral bioavailability (Fz)
研究概览
简要总结
The study will be a comparative oral bioavailability study between GKT137831 capsules and tablets, together with an assessment of the impact of concomitant food intake on the relative bioavailability of GKT137831 tablets.
This will be a randomized three-way open cross-over study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subject, aged 18 to 60 years inclusive;
- •Non-smoker subject or smoker of not more than 5 cigarettes a day ;
- •No history of alcohol or drug abuse
- •Body Mass Index (BMI) between 18 and 27 5 kg/m2 inclusive;
- •Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination);
- •Signing a written informed consent prior to selection;
排除标准
- •Blood donation (including in the frame of a clinical study) within 2 months before administration;
- •General anaesthesia within 3 months before administration;
- •Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician;
- •Inability to abstain from intensive muscular effort;
- •No possibility of contact in case of emergency;
- •Any drug intake (except paracetamol) during the last month prior to the first administration;
- •History or presence of drug or alcohol abuse (alcohol consumption > 40 grams / day);
- •Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day);
- •Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests;
- •Positive results of screening for drugs of abuse;
- •Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
- •Exclusion period of a previous study;
- •Administrative or legal supervision;
研究组 & 干预措施
Treatment A
Single oral dose of 400 mg GKT137831 administered as 4 x 100 mg capsules in fasting conditions.
干预措施: GKT137831 (Drug)
Treatment B:
Single oral dose of 400 mg GKT137831 administered as 1 x 400 mg tablets in fasting conditions.
干预措施: GKT137831 (Drug)
Treatment C
Single oral dose of 400 mg GKT137831 administered as 1 x 400 mg tablets in fed conditions.
干预措施: GKT137831 (Drug)
结局指标
主要结局
Oral bioavailability (Fz)
时间窗: 72 hours
To compare the relative oral bioavailability GKT137831 formulated in capsules or in tablets in healthy male subjects.
Food effect on Oral bioavailability (Fz)
时间窗: 72 hours
To assess the impact of concomitant food intake on the relative bioavailability of GKT137831 after single oral dose administration of a 400 mg GKT137831 tablet in healthy male subjects.
次要结局
- Food effect on oral bioavailability of GKT138184(72 hours)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(7 days)
- Oral bioavailability of GKT138184(72 hours)