Trial Condition(s):

Pharmacokinetics

Relative bioavailability and food effect study with vericiguat to characterize the pediatric formulation in adult healthy subjects

Bayer Identifier:

18581

ClinicalTrials.gov Identifier:

NCT03145038

EudraCT Number:

2016-005074-35

Study Completed

Trial Purpose

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.

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)

Trial Summary

Enrollment Goal
30
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Vericiguat (BAY1021189)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

CRS Clinical-Research-Services Mönchengladbach GmbH

Mönchengladbach, Germany, 41061

Status
Completed
 

Trial Design