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

Bayer

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Vericiguat(BAY1021189,10 mg IR film-coated tablets,crushed)_fed;American breakfast; Drug: Vericiguat(BAY1021189, high-dose pediatric-formulation)_fed; Drug: Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;Continental breakfast; Drug: Vericiguat(BAY1021189, low-dose pediatric-formulation)_fed; Drug: Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;American breakfast; Drug: Vericiguat(BAY1021189, high-dose pediatric-formulation)_fasted

Study type: Interventional

Funder types: Industry

Identifiers

NCT03145038

18581

2016-005074-35 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 6 patient groups

Treatment A

Experimental group

Description:

Single oral dose of 20 x 0.5 mg vericiguat high-dose pediatric formulation, fed, American breakfast

Treatment:

Drug: Vericiguat(BAY1021189, high-dose pediatric-formulation)_fed

Treatment B

Experimental group

Description:

Single oral dose of 20 x 0.5 mg vericiguat high-dose pediatric formulation, fasted

Treatment:

Drug: Vericiguat(BAY1021189, high-dose pediatric-formulation)_fasted

Treatment C

Experimental group

Description:

Single oral dose of 25 x 0.1 mg vericiguat high-dose pediatric formulation, fed, American breakfast

Treatment:

Drug: Vericiguat(BAY1021189, low-dose pediatric-formulation)_fed

Treatment D

Active Comparator group

Description:

Single oral dose of 10 mg vericiguat intact IR tablet, adult formulation, fed, American breakfast

Treatment:

Drug: Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;American breakfast

Treatment E

Experimental group

Description:

Single oral dose of 10 mg vericiguat crushed IR tablet, adult formulation, fed, American breakfast

Treatment:

Drug: Vericiguat(BAY1021189,10 mg IR film-coated tablets,crushed)_fed;American breakfast

Treatment F

Experimental group

Description:

Single oral dose of 10 mg vericiguat intact IR tablet, adult formulation, fed, continental breakfast

Treatment:

Drug: Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;Continental breakfast