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

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03145038
• Other study ID #: 18581
• Secondary ID: 2016-005074-35
• Status: Completed
• Phase: Phase 1
• Start date: May 16, 2017
• Est. completion date: October 9, 2017

Study information

• Verified date: December 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 9, 2017
• Est. primary completion date: August 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

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
• Vericiguat(BAY1021189, high-dose pediatric-formulation)_fasted
Vericiguat high-dose pediatric formulation (fasted),10 mg given as 20 x 0.5 mg mini tablets
• 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
• Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;American breakfast
10 mg IR tablet, intact (fed; American breakfast)
• Vericiguat(BAY1021189,10 mg IR film-coated tablets,crushed)_fed;American breakfast
10 mg IR tablet, crushed (fed; American breakfast)
• Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;Continental breakfast
10 mg IR tablet, intact (fed; Continental breakfast)

Locations

Country	Name	City	State
Germany	CRS Clinical-Research-Services Mönchengladbach GmbH	Mönchengladbach	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vericiguat area under the plasma concentration vs. time curve divided by dose (AUC/D)	AUC is the area under the curve (mathematically known as definite integral) in a plot of concentration of vericiguat after single dose administration in blood plasma against time (pre-dose until 72 hours after administration). AUC from time 0 to the last data point greater than lower limit of quantification divided by dose (AUC(0-tlast)/D) will be used as primary parameter if AUC cannot be calculated for all profiles, or mean AUC from the last data point to infinity [AUC(tlast-8)] >20% of AUC. AUC will be analyzed by means of descriptive statistics.	0 - 72 hours
Primary	Vericiguat maximum plasma concentration divided by dose (Cmax/D))	Cmax is the maximum observed vericiguat concentration in measured plasma after single dose administration (pre-dose until 72 hours after administration). Cmax/D is the maximum observed drug concentration in measured matrix after single dose administration divided by dose.Cmax will be analyzed by means of descriptive statistics	0 - 72 hours
Secondary	Number of Adverse Events	As a secondary objective of this study the numbers of AEs will be used to assess safety and tolerability of vericiguat.; In a clinical study, an AE is any untoward medical occurrence (i.e. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a patient or clinical investigation subject after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.; Individual listings of AEs will be provided. The incidence of treatment-emergent AEs an drug-related AEs, respectively, will be summarized by treatment using MedDRA terms (highly specific standardised medical terminology).	pre-dose until 7 to 14 days after last administration of vericiguat
Secondary	Palatability of the oro-dispersible tablets and the crushed IR tablets assessed by questionnaire	As a secondary objective of this study the taste and texture of pediatric formulation (palatability) (mini tablets) and of the crushed IR tablet will be assessed	up to 5 minutes after drug administration

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