check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

15526

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2011-000036-28

EU CT Number:

Not Available
BAY94-8862, Rel. Bioavailability and food effect study

Trial purpose

Primary objective: To investigate the pharmacokinetics (PK) of BAY 94-8862 after single oral doses of a 1.25 mg immediate release (IR) tablet, a 10 mg IR tablet and four 1.25 mg IR tablets (= 5 mg of BAY 94-8862) in the fasted state in healthy male subjects in a randomized, open-label, 3-fold crossover design.
Secondary objectives: To assess safety and tolerability of BAY 94-8862.

Key Participants Requirements

Sex

Male

Age

18 - 46 Years
  • - Healthy male white subjects; 18 to 46 years of age; body mass index: ≥18 and ≤29.9 kg/m*2


  • - Clinically relevant changes/deviations from normal ECG, clinical examination, clinical chemistry, hematology, urinalysis, and/or blood pressure, heart rate (vital signs), or physical examination
    - Regular use of therapeutic or recreational drugs
    - Positive testing in drug screening and or alcohol breath test
    - 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 organs or 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, diagnosed malignancy, psychiatric disorders
    - Regular daily consumption of an amount of beer, alcohol, xanthine-containing beverages, and/or cigarettes that may affect study results
    - Intake of foods or beverages containing grapefruit within 2 weeks before study drug administration
    - Regular use of medicines and use of medication within the 2 weeks preceding the study, especially strong CYP3A4 inducers, weak to moderate CYP3A4 inhibitors and strong inhibitors of CYP3A4 or strong inhibitors of CYP2C8
    - Excluded therapies (eg physiotherapy, acupuncture, etc)
    - Clinically relevant findings in the physical examination
    - Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2) (under Laboratory examinations)
    - Serum potassium level greater than equal to 5.0 mmol/L or serum sodium level less than equal to130 mmol/L

Trial summary

Enrollment Goal
12
Trial Dates
March 2011 - May 2011
Phase
Phase 1
Could I Receive a placebo
No
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Wuppertal, 42096, Germany

Primary Outcome

  • AUC: Area under the concentration vs time curve from zero to infinity after single dose
    date_rangeTime Frame:
    Pre-dose and up to 48 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUC/D: AUC divided by dose
    date_rangeTime Frame:
    Pre-dose and up to 48 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax: Maximum observed drug concentration in plasma after single dose administration
    date_rangeTime Frame:
    Pre-dose and up to 48 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax/D: Cmax divided by dose
    date_rangeTime Frame:
    Pre-dose and up to 48 h post-dose
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • AUCnorm: AUC divided by dose per kg body weight
    date_rangeTime Frame:
    Pre-dose and up to 48 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax,norm: Cmax divided by dose per kg body weight
    date_rangeTime Frame:
    Pre-dose and up to 48 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • t1/2: Half-life associated with the terminal slope
    date_rangeTime Frame:
    Pre-dose and up to 48 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • tmax: Time to reach Cmax
    date_rangeTime Frame:
    Pre-dose and up to 48 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • MRT: Mean residence time
    date_rangeTime Frame:
    Pre-dose and up to 48 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • CL/F: Total body clearance of drug calculated after extravascular administration (apparent oral clearance)
    date_rangeTime Frame:
    Pre-dose and up to 48 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 48 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tlast): AUC from time 0 to the last data point > lower limit of quantification (LLOQ)
    date_rangeTime Frame:
    Pre-dose and up to 48 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately 6 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Relative bioavailability study to investigate the pharmacokinetics, safety and tolerability of single oral doses of BAY 94-8862 given as 1.25 mg IR tablet in comparison to a 10 mg IR tablet and 4 x 1.25 mg IR tablet in healthy male subjects in a randomized, open-label, three-fold crossover design.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
3

Additional Information

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