NCT03145038 - Relative Bioavailability and Food Effect Study With Vericiguat to Characterize the Pediatric Formulation in Adult Healthy Subjects | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 16, 2017

Primary Completion Date

August 29, 2017

Study Completion Date

October 9, 2017

Conditions

Pharmacokinetics

Interventions

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)

Trial Locations (1)

CRS Clinical-Research-Services Mönchengladbach GmbH, Mönchengladbach