check_circleStudy Completed

Clinical pharmacology

Bayer Identifier:

15355

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2011-001627-21

EU CT Number:

Not Available
Single dose escalation study of BAY1021189

Trial purpose

Primary objective: To investigate the safety and tolerability of BAY1021189 after single oral doses of 0.5 mg up to 20 mg administered as solution in healthy male subjects.
Secondary objectives: To investigate the pharmacodynamics and pharmacokinetics of BAY1021189.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - Healthy young male subjects, 18 to 45 years of age, with body mass index between 18.0 and 29.9 kg/m2
  • - Clinically relevant changes/deviations from normal ECG, physical examination, clinical chemistry, hematology, urinalysis, and/or blood pressure, heart rate (vital signs)
    - Regular use of therapeutic or recreational drugs
    - Positive testing in drug or urine screening
    - Recent donation of blood/blood components
    - Subjects hypersensitive to the investigational drugs, their components and/or with a history of multiple drug allergies, non-allergic drug reactions, or severe allergies
    - History of/current relevant diseases of vital or other organs and of the central nervous system and/or medical conditions/disorder/illness that would impair subject’s ability to participate in the trial or that may affect study results
    - Regular daily consumption of an amount of beer, alcohol, xanthine-containing beverages, and/or cigarettes that may affect study results
    - Recent or current use of medication which could interfere with the investigational products
    - Incompletely cured pre-existing diseases for which it could be assumed that the absorption, distribution, metabolism, elimination or effects of the study drug would not have been normal
    - Regular use of medicines
    - All types of tobacco smoking in the non-smoker groups within the last 4 weeks prior to study drug administration
    - Suspicion of drug or alcohol abuse
    - Special diets preventing the subject from eating the standard meals during the study - Intake of foods or beverages containing grapefruit within 1 week before study drug administration
    - Excluded therapies within 1 month before study drug administration
    - Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), or human immune deficiency virus antibodies (anti-HIV 1+2) - History of postural syncopes

Trial summary

Enrollment Goal
69
Trial Dates
July 2011 - April 2012
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Wuppertal, 42096, Germany

Primary Outcome

  • AUC
    Area under the plasma concentration vs time curve from zero to infinity for total (bound and unbound) drug after single dose
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUC/D
    AUC divided by dose
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax
    Maximum total (bound and unbound) drug concentration in plasma after single dose administration
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax/D
    Cmax divided by dose
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Cmax,norm
    Cmax divided by dose per kg body weight
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • tmax
    Time to reach Cmax (in case of 2 identical Cmax values, the first tmax was to be used)
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • t½
    Half-life associated with the terminal slope
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • MRT
    Mean residence time
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUCnorm
    AUC divided by dose per kg body weight
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tlast)
    AUC from time 0 to the last data point
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tlast)norm
    AUC(0-tlast) divided by dose per kg body weight
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Vz/F
    Apparent volume of distribution during terminal phase after extravascular administration
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AE,ur
    Amount of drug excreted into urine, only calculated for dose steps where drug concentrations in urine were measured
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • %AE,ur
    Percent of drug excreted into urine, only calculated for dose steps where drug concentrations in urine were measured
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • CLR
    Renal body clearance of drug only calculated for dose steps where drug concentrations in urine were measured
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • CL/F
    Total body clearance of drug calculated after extravascular administration (eg apparent oral clearance)
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • HR
    Heart rate
    date_rangeTime Frame:
    Approximately 4 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • HR over 1 min
    Heart rate over 1 min
    date_rangeTime Frame:
    From 24 h prior to dosing and up to 24 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Standing BP procedure
    Standing blood pressure procedure
    date_rangeTime Frame:
    From 22 h prior to dosing and up to 4 h post-dose
    enhanced_encryption
    Safety Issue:
    Yes
  • Impedance cardiography
    Stroke volume, cardiac output, heart rate, cardiac index = cardiac output / body surface area
    date_rangeTime Frame:
    From 24 h prior to dosing and up to 24 post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Vasoactive hormones
    Plasma renin activity, plasma angiotensin II, noradrenaline, adrenaline, and cyclic guanosine monophosphate as well as serum aldosterone
    date_rangeTime Frame:
    From 24 h prior to dosing and up to 48 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Biomarkers
    B-type natriuretic peptide (BNP), n-terminal prohormone of BNP, asymmetric dimethylarginine and osteopontin
    date_rangeTime Frame:
    From 24 h prior to dosing and up to 24 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately 4 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • BP
    Blood pressure
    date_rangeTime Frame:
    Approximately 4 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Single dose, single-blind, randomized, placebo-controlled dose escalation study to investigate safety, tolerability, pharmacokinetic, and pharmacodynamic properties of BAY 1021189 after oral dosing in 10 healthy male non-smoking subjects per dose step and 10 healthy male smoking subjects in one dose step in addition
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
Single Blind
Assignment
Parallel Assignment
Trial Arms
9

Additional Information

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