Relative Bioavailability and Food Effect Study With Vericiguat to Characterize the Pediatric Formulation in Adult Healthy Subjects

• Status: Completed
• Trial end date: 2017-10-09
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)