Clinical trial NCT03145038: Relative Bioavailability and Food Effect Study With Vericiguat to Characterize the Pediatric Formulation in Adult Healthy Subjects
Official title: Relative Bioavailability and Food Effect Study With Vericiguat to Characterize the Pediatric Formulation in Adult Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-05-09
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.


Eligibility 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)

Primary outcomes:
measure: Vericiguat area under the plasma concentration vs. time curve divided by dose (AUC/D)
timeFrame: 0 - 72 hours
measure: Vericiguat maximum plasma concentration divided by dose (Cmax/D))
timeFrame: 0 - 72 hours
Secondary outcomes:
measure: Number of Adverse Events
timeFrame: pre-dose until 7 to 14 days after last administration of vericiguat
measure: Palatability of the oro-dispersible tablets and the crushed IR tablets assessed by questionnaire
timeFrame: up to 5 minutes after drug administration
Other outcomes:
Locations:
city: Mönchengladbach
country: Germany
facility: CRS Clinical-Research-Services Mönchengladbach GmbH
state: Nordrhein-Westfalen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: