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

NCT ID: NCT03145038

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-16

Study Completion Date

2017-10-09

Brief Summary

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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.

Detailed Description

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Conditions

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Pharmacokinetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Treatment A

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Vericiguat high-dose pediatric formulation (fed; American breakfast), 10 mg given as 20 x 0.5 mg mini tablets

Treatment B

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Vericiguat high-dose pediatric formulation (fasted),10 mg given as 20 x 0.5 mg mini tablets

Treatment C

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Vericiguat low-dose pediatric-formulation (fed; American breakfast), 2.5 mg given as 25 x 0.1 mg mini tablets

Treatment D

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

10 mg IR tablet, intact (fed; American breakfast)

Treatment E

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

10 mg IR tablet, crushed (fed; American breakfast)

Treatment F

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

10 mg IR tablet, intact (fed; Continental breakfast)

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

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

10 mg IR tablet, intact (fed; American breakfast)

Intervention Type DRUG

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

10 mg IR tablet, crushed (fed; American breakfast)

Intervention Type DRUG

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

10 mg IR tablet, intact (fed; Continental breakfast)

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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CRS Clinical-Research-Services Mönchengladbach GmbH

Mönchengladbach, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Related Links

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http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products.

Other Identifiers

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2016-005074-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

18581

Identifier Type: -

Identifier Source: org_study_id