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

NCT03145038 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-12-29

No results posted yet for this study

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

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)

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-16
Primary Completion
2017-08-29
Completion
2017-10-09

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03145038 on ClinicalTrials.gov