check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

13782

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2009-011960-12

EU CT Number:

Not Available
BAY94-8862, Single dose titration study

Trial purpose

Primary objective: To investigate the safety and tolerability of BAY 94-8862 after single oral doses starting at 1.0 mg administered as a polyethylene glycol based solution in healthy male subjects. While doses up to 40 mg were planned, the maximum dose depended on the safety, tolerability, and pharmacokinetic results of the previous dose step.
Secondary objectives: To investigate the pharmacodynamics and pharmacokinetics of BAY 94-8862.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - Healthy male white subjects; 18 to 45 years of age; body mass index between 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 electrocardiogram values, clinical 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 which could interfere with the investigational product
    - Concomitant administration of potassium-sparing diuretics, angiotensin-converting enzyme
    inhibitors, nonsteroidal anti-inflammatory drugs or potassium supplements
    - History of peptic ulcers or relevant gastro-esophageal reflux disease
    - Subjects testing positive in the drug screening
    - History of substance abuse, including alcohol abuse or dependence
    - Subject testing positive for human immunodeficiency virus type 1 and 2 antibody, hepatitis B surface antigen or hepatitis C virus antibody

Trial summary

Enrollment Goal
45
Trial Dates
August 2009 - April 2010
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 plasma concentration versus time curve from zero to infinity after single dose
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    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-dose
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    Safety Issue:
    No

Secondary Outcome

  • AUC/D: AUC divided by dose
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
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    Safety Issue:
    No
  • AUCnorm: Area under the curve divided by dose per body weight
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
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    Safety Issue:
    No
  • Cmax/D: Maximum drug concentration in plasma after single dose administration divided by dose
    date_rangeTime Frame:
    Pre-dose and up to 72 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 up to 72 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 up to 72 h post-dose
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    Safety Issue:
    No
  • t½: Half-life associated with the terminal slope
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
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    Safety Issue:
    No
  • MRT: Mean residence time
    date_rangeTime Frame:
    Pre-dose and up to 72 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 up to 72 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 up to 72 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 up to 72 h post-dose
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    Safety Issue:
    No
  • Aeur: Amount of drug excreted via urine (only in the 40 mg dose step)
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
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    Safety Issue:
    No
  • CLR: Renal clearance (only in the 40 mg dose step)
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
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    Safety Issue:
    No
  • BP: Blood pressure
    date_rangeTime Frame:
    Approximately 4 weeks
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    Safety Issue:
    Yes
  • HR over 1 min: Heart rate over 1 min
    date_rangeTime Frame:
    From 24 h prior to dosing to 24 h post-dose
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    Safety Issue:
    Yes
  • Standing BP: Standing blood pressure
    date_rangeTime Frame:
    22 h prior to dosing to 4 h post-dose
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    Safety Issue:
    Yes
  • Neurohormones: Plasma renin activity, serum angiotensin II, serum aldosterone, and serum noradrenaline
    date_rangeTime Frame:
    From 24 h prior to dosing to 24 h post-dose
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    Safety Issue:
    Yes
  • Urine: Urinary volume, sodium, potassium, magnesium, calcium, ratio of urinary sodium/ potassium, the log10 of urinary sodium/potassium ratio, and the log10 of 10*urinary sodium/potassium ratio
    date_rangeTime Frame:
    From 24 h prior to dosing to 24 h post-dose
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    Safety Issue:
    Yes
  • Number of participants with adverse event
    date_rangeTime Frame:
    Approximately 4 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • HR: Heart rate
    date_rangeTime Frame:
    Approximately 4 weeks
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    Safety Issue:
    Yes

Trial design

Single dose, basic phase I dose escalation study in a randomized, single-blind, placebo-controlled, group-comparison design to investigate safety and tolerability of BAY 94-8862 and its pharmacodynamics and pharmacokinetics after oral dosing in 8 healthy male subjects per dose step
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Single Blind
Assignment
Parallel Assignment
Trial Arms
7