Relative Bioavailability and Food Effect Study With Vericiguat to Characterize the Pediatric Formulation in Adult Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Vericiguat area under the plasma concentration vs. time curve divided by dose (AUC/D)
研究概览
简要总结
Vericiguat is intended to be used for the treatment of cardiovascular diseases, especially heart failure. Heart failure also occurs in children. Therefore, a study testing vericiguat in the treatment of heart failure in paediatric patients is planned under the paediatric investigational plan (PIP). In order to administer vericiguat to children, a vericiguat paediatric formulation is needed. This paediatric formulation is characterized in this study prior to its use in paediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subject
- •Age: 18 to 45 years (inclusive) at informed consent
- •Race: white
- •Body Mass Index (BMI): above or equal 18.0 and below or equal 29.9 kg / m²
排除标准
- •Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- •Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
- •Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- •Febrile illness within 1 week prior to the first study drug administration
- •History of postural syncopes
- •A history of relevant diseases of vital organs, of the central nervous system or other organs
- •A history of relevant smell and / or taste disorders
- •Relevant diseases within the last 4 weeks prior to the first study drug administration
- •Medical disorder that would impair the subject's ability to complete the study in the opinion of the investigator.
- •Known gastro-intestinal disorders (e.g. stomach ulcers, duodenal ulcers, gastrointestinal bleeding) or inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)
研究组 & 干预措施
Treatment A
Single oral dose of 20 x 0.5 mg vericiguat high-dose pediatric formulation, fed, American breakfast
干预措施: Vericiguat(BAY1021189, high-dose pediatric-formulation)_fed (Drug)
Treatment B
Single oral dose of 20 x 0.5 mg vericiguat high-dose pediatric formulation, fasted
干预措施: Vericiguat(BAY1021189, high-dose pediatric-formulation)_fasted (Drug)
Treatment C
Single oral dose of 25 x 0.1 mg vericiguat high-dose pediatric formulation, fed, American breakfast
干预措施: Vericiguat(BAY1021189, low-dose pediatric-formulation)_fed (Drug)
Treatment D
Single oral dose of 10 mg vericiguat intact IR tablet, adult formulation, fed, American breakfast
干预措施: Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;American breakfast (Drug)
Treatment E
Single oral dose of 10 mg vericiguat crushed IR tablet, adult formulation, fed, American breakfast
干预措施: Vericiguat(BAY1021189,10 mg IR film-coated tablets,crushed)_fed;American breakfast (Drug)
Treatment F
Single oral dose of 10 mg vericiguat intact IR tablet, adult formulation, fed, continental breakfast
干预措施: Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;Continental breakfast (Drug)
结局指标
主要结局
Vericiguat area under the plasma concentration vs. time curve divided by dose (AUC/D)
时间窗: 0 - 72 hours
AUC is the area under the curve (mathematically known as definite integral) in a plot of concentration of vericiguat after single dose administration in blood plasma against time (pre-dose until 72 hours after administration). AUC from time 0 to the last data point greater than lower limit of quantification divided by dose (AUC(0-tlast)/D) will be used as primary parameter if AUC cannot be calculated for all profiles, or mean AUC from the last data point to infinity \[AUC(tlast-∞)\] \>20% of AUC. AUC will be analyzed by means of descriptive statistics.
Vericiguat maximum plasma concentration divided by dose (Cmax/D))
时间窗: 0 - 72 hours
Cmax is the maximum observed vericiguat concentration in measured plasma after single dose administration (pre-dose until 72 hours after administration). Cmax/D is the maximum observed drug concentration in measured matrix after single dose administration divided by dose.Cmax will be analyzed by means of descriptive statistics
次要结局
- Number of Adverse Events(pre-dose until 7 to 14 days after last administration of vericiguat)
- Palatability of the oro-dispersible tablets and the crushed IR tablets assessed by questionnaire(up to 5 minutes after drug administration)