A Part-randomised, Single Centre, Single Dose, Crossover,Phase I Study to Investigate the Impact of Changes to the Dosing Regimen on the Pharmacokinetic Profile of ODM-203 in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration curve(AUC) ODM-203 in the presence and absence of food
研究概览
简要总结
This Phase I study in healthy male volunteers will evaluate the impact of the effect of food on the pharmacokinetic profile of ODM-203.
详细描述
This study will be a single dose part randomised cross over study with up to 6 study periods. ODM-203 may be dosed using a variety of different conditions with respect to food depending on emerging data. The impact of changing the presentation of ODM-203 may also be assessed to determine the PK of alternative formulations and identify appropriate drug formulations for further development.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Able to speak, write and understand English
- •Body mass index of 18.0-32.0
- •Weight 55-95 kg
- •Adequate method of contraception
- •Good state of health
排除标准
- •Receipt of IMP in a clinical research study or donation/loss of >400ml blood within previous 3 months or previously enrolled in this study
- •History of drug or alcohol abuse or positive drugs of abuse test or regular alcohol consumption or current smoker/user of nicotine replacement products
- •Positive drugs of abuse test
- •Positive hepatitis B, hepatitis C or HIV results
- •Donation/loss of >400ml blood within previous 3 months
- •Poor compliance or inability to follow protocol requirements/instructions/restrictions.
- •Vulnerable subjects
- •Evidence of clinically relevant disease of any body system including relevant psychiatric disorders or conditions requiring regular concomitant medication
- •History of significant hypersensitivity, anaphylaxis, intolerance to drugs/food
- •Propensity to get headaches when refraining from caffeine containing beverages
- •Any abnormal laboratory value, vital signs, ECG parameter or physical examination interfering with the test results or causing a health risk for the subject or failure to satisfy the investigator of fitness to participate for any other reason.
研究组 & 干预措施
Period 1
ODM-203 dosed after food
干预措施: ODM-203 (Period 1) (Drug)
Period 2
ODM-203 dosed before food
干预措施: ODM-203 (Period 2) (Drug)
Periods 3-6
ODM-203 dosed as a tablet or dispersion
干预措施: ODM-203 (Periods 3-6) (Drug)
结局指标
主要结局
Area under the plasma concentration curve(AUC) ODM-203 in the presence and absence of food
时间窗: 0 to 72 hours
Area under the plasma concentration curve (AUC) will be measured to investigate the pharmacokinetic profile of ODM-203 in the presence and absence of food
次要结局
- Number of adverse events(From the date of informed consent to the date of the end of study estimated to be up to 17 weeks)
- Area under the plasma concentration curve(AUC) ORM-21444 in the presence and absence of food(0 to 72 hours)