check_circleStudy Completed

Clinical pharmacology

Bayer Identifier:

15811

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2012-000932-25

EU CT Number:

Not Available
BAY1021189, Omeprazol/Antacida Interaction Study

Trial purpose

Primary objective:
To investigate the influence of a co-administration of a single dose of 10 mL Maalox® 70 mVal Suspension and a 4 day pre- and one time co-treatment of 2 x 20 mg Antra® once daily on the pharmacokinetics of 5 mg BAY 1021189 in comparison to 5 mg BAY 1021189 alone, both given orally as 4 x 1.25 mg immediate release tablets, in a three-fold crossover, randomized, open label design in healthy male subjects.
Secondary objectives: To assess safety and tolerability of BAY 1021189.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - Healthy, white male subjects, 18 to 45 years of age, body mass index: between ≥18.0 and ≤29.9 kg/m2

  • - 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
    - Incompletely cured pre-existing diseases for which it could have been assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs were not normal
    - 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 testing positive in the drug screening
    - Positive urine drug screening
    - Special diets preventing the subjects from eating the standard meals during the study

Trial summary

Enrollment Goal
12
Trial Dates
May 2012 - December 2012
Phase
Phase 1
Could I Receive a placebo
No
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 after single (first) dose
    date_rangeTime Frame:
    Pre-dose and up to 72 h post administration
    enhanced_encryption
    Safety Issue:
    No
  • Cmax
    Maximum drug concentration in plasma after single dose administration
    date_rangeTime Frame:
    Pre-dose and up to 72 h post administration
    enhanced_encryption
    Safety Issue:
    No
  • Cmax/C(24h)
    Ratio of maximum drug concentration in plasma after single dose administration and drug concentration at 24 h post dosing
    date_rangeTime Frame:
    Pre-dose and up to 72 h post administration
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Cmax/D
    Maximum drug concentration in plasma after single dose administration divided by dose (mg)
    date_rangeTime Frame:
    Pre-dose and up to 72 h post administration
    enhanced_encryption
    Safety Issue:
    No
  • tmax
    Time to reach maximum drug concentration in plasma after single (first) dose
    date_rangeTime Frame:
    Pre-dose and up to 72 h post administration
    enhanced_encryption
    Safety Issue:
    No
  • t½
    Half-life associated with the terminal slope
    date_rangeTime Frame:
    Pre-dose and up to 72 h post administration
    enhanced_encryption
    Safety Issue:
    No
  • AUC/D
    AUC divided by dose (mg)
    date_rangeTime Frame:
    Pre-dose and up to 72 h post administration
    enhanced_encryption
    Safety Issue:
    No
  • Cmax/D
    Maximum drug concentration in plasma after single dose administration divided by dose (mg)
    date_rangeTime Frame:
    Pre-dose and up to 72 h post administration
    enhanced_encryption
    Safety Issue:
    No
  • CL/f
    Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance)
    date_rangeTime Frame:
    Pre-dose and up to 72 h post administration
    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 administration
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately eight weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Interaction study to investigate the influence of a co-administration of a single dose of 10 mL Maalox® and a 4 days pre- and co-treatment with Antra® 2 x 20 mg OD, respectively, on the pharmacokinetics of a single dose of 5 mg BAY 1021189, taken as 4 x 1.25 mg IR tablets, in a threefold crossover, randomized, open label design in healthy male subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
3

Additional Information

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