check_circleStudy Completed

Pharmacokinetics

Bayer Identifier:

18581

ClinicalTrials.gov Identifier:

NCT03145038

EudraCT Number:

2016-005074-35

EU CT Number:

Not Available
Relative bioavailability and food effect study with vericiguat to characterize the pediatric formulation in adult healthy subjects

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - 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

  • - 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)

Trial summary

Enrollment Goal
30
Trial Dates
May 2017 - October 2017
Phase
Phase 1
Could I Receive a placebo
No
Products
Vericiguat (BAY1021189)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical-Research-Services Mönchengladbach GmbHMönchengladbach, 41061, Germany

Primary Outcome

  • 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-∞)] >20% of AUC. AUC will be analyzed by means of descriptive statistics.
    date_rangeTime Frame:
    0 - 72 hours
  • 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
    date_rangeTime Frame:
    0 - 72 hours

Secondary Outcome

  • 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).
    date_rangeTime Frame:
    pre-dose until 7 to 14 days after last administration of vericiguat
  • 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
    date_rangeTime Frame:
    up to 5 minutes after drug administration

Trial design

Relative bioavailability and food effect study with vericiguat to characterize the pediatric formulation in adult healthy subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Non-randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
6

Additional Information

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