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.
- 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
- 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)
CRS Clinical-Research-Services Mönchengladbach GmbH
Mönchengladbach, Germany, 41061
E-mail: [email protected]
Phone: (+) 1-888-8422937
Relative bioavailability and food effect study with vericiguat to characterize the pediatric formulation in adult healthy subjects