Skip to main content
OpenTrials
Completed

NCT Number: NCT03145038

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pharmacokinetics

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical-Research-Services Mönchengladbach GmbH

Mönchengladbach, North Rhine-Westphalia, 41061, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Drug

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

Drug

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

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

Drug

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

Drug

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

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

Drug

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

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

Drug

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

Primary outcomes

  1. Vericiguat area under the plasma concentration vs. time curve divided by dose (AUC/D)

    Time frame: 0 - 72 hours

    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-∞)] >20% of AUC. AUC will be analyzed by means of descriptive statistics.

  2. Vericiguat maximum plasma concentration divided by dose (Cmax/D))

    Time frame: 0 - 72 hours

    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

Secondary outcomes

  1. Number of Adverse Events

    Time frame: pre-dose until 7 to 14 days after last administration of vericiguat

    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).

  2. Palatability of the oro-dispersible tablets and the crushed IR tablets assessed by questionnaire

    Time frame: up to 5 minutes after drug administration

    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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 9, 2017
Registry last updated
Dec 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.