check_circleStudy Completed

Clinical Pharmacology

BAY94-8862, Age and Gender Study

Trial purpose

Primary objective: To investigate the influence of age and gender on the pharmacokinetics of BAY 94-8862 given as a 10 mg immediate-release tablet single dose in young and elderly healthy male and female subjects (of non-childbearing potential)
Secondary objectives: To assess safety and tolerability of BAY 94-8862

Key Participants Requirements

Sex

Both

Age

18 - 80 Years

Trial summary

Enrollment Goal
48
Trial Dates
February 2011 - September 2011
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Köln, 51063, Germany

Primary Outcome

  • AUC: Area under the concentration vs time curve from zero to infinity after single dose for BAY 94-8862, BAY 1040818 (M1), BAY 1088089 (M2), and BAY 1088090 (M3)
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUCnorm: AUC divided by dose per body weight for BAY 94-8862, BAY 1040818 (M1), BAY 1088089 (M2), and BAY 1088090 (M3)
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax: Maximum observed drug concentration in plasma after single dose administration for BAY 94-8862, BAY 1040818 (M1), BAY 1088089 (M2), and BAY 1088090 (M3)
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax,norm: Cmax divided by dose per body weight for BAY 94-8862, BAY 1040818 (M1), BAY 1088089 (M2), and BAY 1088090 (M3)
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • AUC/D: AUC divided by dose for BAY 94-8862
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax/D: Cmax divided by dose for BAY 94-8862
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • tmax: Time to reach Cmax in plasma after single dose for BAY 94-8862, BAY 1040818 (M1), BAY 1088089 (M2), and BAY 1088090 (M3)
    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 for BAY 94-8862, BAY 1040818 (M1), BAY 1088089 (M2), and BAY 1088090 (M3)
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • MRT: Mean residence time for BAY 94-8862
    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 (apparent oral clearance in this study) for BAY 94-8862
    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 for BAY 94-8862
    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 > lower limit of quantification for BAY 94-8862
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Heart rate over 1 min
    date_rangeTime Frame:
    From 24 h prior to dosing to 4 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Neurohormones: Plasma renin activity, angiotensin II, and aldosterone
    date_rangeTime Frame:
    From 24 h prior to dosing to 24 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately 5 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • HR: Heart rate
    date_rangeTime Frame:
    Approximately 5 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • BP: Blood pressure
    date_rangeTime Frame:
    Approximately 5 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Study to investigate the influence of age and gender on the pharmacokinetics of a single oral dose of a 10 mg BAY 94-8862 IR tablet in a randomized, single-blind, placebo-controlled, group-comparison design in healthy male and female subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Single Blind
Assignment
Parallel Assignment
Trial Arms
5