NCT03145038

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Vericiguat(BAY1021189, high-dose pediatric-formulation)_fed	Vericiguat high-dose pediatric formulation (fed; American breakfast), 10 mg given as 20 x 0.5 mg mini tablets
DRUG	Vericiguat(BAY1021189, high-dose pediatric-formulation)_fasted	Vericiguat high-dose pediatric formulation (fasted),10 mg given as 20 x 0.5 mg mini tablets
DRUG	Vericiguat(BAY1021189, low-dose pediatric-formulation)_fed	Vericiguat low-dose pediatric-formulation (fed; American breakfast), 2.5 mg given as 25 x 0.1 mg mini tablets
DRUG	Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;American breakfast	10 mg IR tablet, intact (fed; American breakfast)
DRUG	Vericiguat(BAY1021189,10 mg IR film-coated tablets,crushed)_fed;American breakfast	10 mg IR tablet, crushed (fed; American breakfast)
DRUG	Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;Continental breakfast	10 mg IR tablet, intact (fed; Continental breakfast)

Timeline

• Start date: 2017-05-16
• Primary completion: 2017-08-29
• Completion: 2017-10-09
• First posted: 2017-05-09
• Last updated: 2021-12-29

Locations

1 site across 1 country: Germany