check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

13784

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2010-019192-30

EU CT Number:

Not Available
BAY94-8862,Relative bioavailability and food effect study

Trial purpose

Primary objective: To investigate pharmacokinetics of BAY 94-8862 after single oral doses of 10 mg polyethylene glycol solution, 10 mg immediate release (IR) tablet and eight 10 mg IR tablets (= 80 mg of BAY 94-8862) in the fasted state and 10 mg IR tablet with a high-fat, high-calorie breakfast in healthy male subjects in a randomized, open-label, four-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.

  • - Subjects with conspicuous findings in medical history and pre-study examination
    - Recent donation of blood/blood components
    - Clinically relevant changes/deviations from normal electrocardiography, 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
    - History of/current relevant diseases of vital or other organs and of the central nervous system and/or medical conditions that would impair subject’s ability to participate in the trial or 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, especially, Concomitant administration of potassium-sparing diuretics, ACE inhibitors, angiotensin-II-receptor blockers, potassium or calcium supplements, nonsteroidal anti-inflammatory drugs like acetylsalicylic acid, indomethacin or ibuprofen, concomitant use of strong CYP3A4 inducers and inhibitors, weak to moderate CYP3A4 inhibitors
    - Subjects testing positive in the drug screening or alcohol breath test
    - Subject testing positive for human immunodeficiency virus type 1 and 2 antibody, hepatitis B surface antigen or hepatitis C virus antibody
    - Serum potassium level greater than equal to 5.0 mmol/L, serum sodium level less than equal to 130 mmol/L

Trial summary

Enrollment Goal
15
Trial Dates
May 2010 - July 2010
Phase
Phase 1
Could I Receive a placebo
No
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Köln, 51063, Germany

Primary Outcome

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

Secondary Outcome

  • AUCnorm (Area under the curve divided by dose per body weight)
    date_rangeTime Frame:
    Pre-dose and 48 h post-dose
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    Safety Issue:
    No
  • Cmax,norm (Maximum drug concentration in plasma after single dose administration divided by dose per body weight)
    date_rangeTime Frame:
    Pre-dose and 48 h post-dose
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    Safety Issue:
    No
  • tmax (Time to reach maximum drug concentration in plasma after single dose)
    date_rangeTime Frame:
    Pre-dose and 48 h post-dose
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    Safety Issue:
    No
  • t½ (Half-life associated with the terminal slope)
    date_rangeTime Frame:
    Pre-dose and 48 h post-dose
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    Safety Issue:
    No
  • MRT (Mean residence time)
    date_rangeTime Frame:
    Pre-dose and 48 h post-dose
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    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 48 h post-dose
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    Safety Issue:
    No
  • Vz/f (Apparent volume of distribution during terminal phase after oral administration)
    date_rangeTime Frame:
    Pre-dose and 48 h post-dose
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    Safety Issue:
    No
  • AUC(0-tn) (AUC from zero to the last data point)
    date_rangeTime Frame:
    Pre-dose and 48 h post-dose
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    Safety Issue:
    No
  • BP (Blood pressure)
    date_rangeTime Frame:
    Approximately 6 weeks
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    Safety Issue:
    Yes
  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately 6 weeks
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    Safety Issue:
    Yes
  • HR (Heart rate)
    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 10 mg IR tablet in comparison to a 10 mg solution and 8 x 10 mg IR tablet in the fasting condition and to investigate the effect of a high fat, high calorie meal on the 10 mg IR tablet in healthy male subjects in a randomized, open-label, four-fold crossover design
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
4