check_circleStudy Completed

Clinical pharmacology

Bayer Identifier:

15356

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2011-004841-42

EU CT Number:

Not Available
Relative bioavailability and food interaction study of BAY1021189

Trial purpose

Primary objectives:
- Pharmacokinetics of BAY 1021189 after single oral doses of 1.25 mg and 5 mg immediate release tablets in comparison to 5 mg administered as oral solution
- Influence of food (high-fat, high-calorie breakfast) on the pharmacokinetics of BAY 1021189 after single oral administration of a 5 mg IR tablet.
Secondary objectives:
- Safety, tolerability and pharmacodynamics of BAY 1021189.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - Healthy white male volunteers, age 18-45 years, body mass index: ≥ 18 and ≤ 29.9 kg/m²

  • - Recent donation of blood/blood components
    - Clinically relevant changes/deviations from normal ECG, physical examination, clinical chemistry, hematology, urinalysis, and/or blood pressure, heart rate (vital signs)
    - Regular daily consumption of an amount of beer, alcohol, xanthine-containing beverages, foods or beverages containing grapefruit and/or cigarettes that may affect study results
    - Subjects with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies or with hypersensitivity to the investigational drug, the control agent and/or to inactive constituents
    - Regular use of therapeutic or recreational drugs
    - Use of medication within the 2 weeks preceding the study which could interfere with the investigational product
    - Subjects testing positive in the drug screening
    - Incompletely cured pre-existing diseases for which it could be assumed that
    the absorption, distribution, metabolism, elimination and effects of the study
    drugs were not be normal
    - Subject testing positive for human immunodeficiency virus type 1 and 2 antibody, hepatitis B surface antigen or hepatitis C virus antibody
    - Special diets preventing the subjects from eating the standard meals during the study
    - History of postural syncopes

Trial summary

Enrollment Goal
16
Trial Dates
December 2011 - June 2012
Phase
Phase 1
Could I Receive a placebo
No
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Wuppertal, 42113, Germany

Primary Outcome

  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately 8 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • BP
    Blood pressure
    date_rangeTime Frame:
    Approximately 8 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • HR over 1 min
    Heart rate over 1 min
    date_rangeTime Frame:
    Pre-dose and up to 24 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Plasma cGMP
    Plasma cyclic guanosine monophosphate
    date_rangeTime Frame:
    Pre-dose and up to 24 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Impedance cardiography
    The following variables were measured: stroke volume, cardiac output, heart rate, cardiac index
    date_rangeTime Frame:
    Pre-dose and up to 8 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • HR
    Heart rate
    date_rangeTime Frame:
    Approximately 8 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • AUC
    Area under the plasma concentration vs time curve from zero to infinity after single dose
    date_rangeTime Frame:
    From pre-dose up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUC/D
    AUC divided by dose (mg)
    date_rangeTime Frame:
    From pre-dose up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax/D
    Maximum drug concentration in plasma after single dose administration divided by dose (mg)
    date_rangeTime Frame:
    From pre-dose up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax
    Maximum drug concentration in plasma after single dose administration
    date_rangeTime Frame:
    From pre-dose up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • AUCnorm
    Area under the curve divided by dose per kg body weight
    date_rangeTime Frame:
    From pre-dose up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax,norm
    Maximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weight
    date_rangeTime Frame:
    From pre-dose up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • tmax
    Time to reach maximum drug concentration in plasma after single dose
    date_rangeTime Frame:
    From pre-dose up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • t½
    Half-life associated with the terminal slope
    date_rangeTime Frame:
    From pre-dose up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • CL/F
    Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance)
    date_rangeTime Frame:
    From pre-dose up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Vz/F
    Apparent volume of distribution during terminal phase after oral administration
    date_rangeTime Frame:
    From pre-dose up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No

Trial design

Relative bioavailability study to investigate safety, tolerability, pharmacodynamics and pharmacokinetics of 1.25 mg and 5 mg BAY 1021189 IR tablets in comparison to 5 mg oral solution, and to investigate the influence of a high fat, high calorie meal on the 5 mg IR tablet in 16 healthy male subjects in a single dose, randomized, open-label, four-fold cross-over design
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
4

Additional Information

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