check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

14508

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2010-023874-38

EU CT Number:

Not Available
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
  • - Healthy subjects were assigned to 1 of 4 age and gender groups ie young men aged 18 – 45 years, elderly male subjects aged 65 – 80 years (was to include approximately 4 – 6 subjects aged ≥73 years) as well as young and elderly women (same age limits as for men).

  • - 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
    - Subjects should not take any concomitant chronic medication, except aspirin for cardioprotection; thyroid hormone replacement, provided the serum T3, T4 and TSH values are normal at Screening; topical anti-glaucoma medications; topical medications including artificial tears, dry skin creams and topical steroid preparations; low dose estrogen for hormone replacement. Vitamins or multivitamins with or without calcium and/or iron may be taken up to Day -1 and may be resumed on Day 4

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