check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

14504

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2012-000736-25

EU CT Number:

Not Available
BAY94-8862, 3A4 Inhibitor erythromycim study

Trial purpose

Primary objective: To investigate the influence of multiple oral doses of 500 mg erythromycin tid on the safety, tolerability, pharmacodynamics, and pharmacokinetics of 1.25 mg BAY 94-8862 given as a single oral dose in comparison to 1.25 mg BAY 94-8862 given alone.

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 ECG, 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 study drug or interacting drug, the control agent and/or to inactive constituents, especially hypersensitivity to macrolides antibiotics
    - Regular use of therapeutic or recreational drugs, eg carnitine products, anabolics, high-dose vitamins
    - 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
    - Comedication with antihistamines, cisapride or pimozide, colistin, chloramphenicol, clindamycin, lincomycin, streptomycin or other tetracyclines, and medicines, which are known to prolong the QT interval
    - Subjects testing positive in the drug screening
    - Suspicion of drug abuse, including alcohol abuse
    - 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
16
Trial Dates
April 2012 - August 2012
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 concentration-vs-time curve from zero to infinity after single dose for BAY 94-8862 and its metabolites M1 (BAY 1040818), M2 (BAY 1088089), and M3 (BAY 1088090))
    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 for BAY 94-8862 and its metabolites M1 (BAY 1040818), M2 (BAY 1088089), and M3 (BAY 1088090))
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • tmax :Time to reach maximum drug concentration in plasma after single dose for BAY 94-8862 and its metabolites M1 (BAY 1040818), M2 (BAY 1088089), and M3 (BAY 1088090)
    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 and its metabolites M1 (BAY 1040818), M2 (BAY 1088089), and M3 (BAY 1088090)
    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 and its metabolites M1 (BAY 1040818), M2 (BAY 1088089), and M3 (BAY 1088090)
    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 (eg apparent oral clearance) for BAY 94-8862 and its metabolites M1 (BAY 1040818), M2 (BAY 1088089), and M3 (BAY 1088090)
    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 and its metabolites M1 (BAY 1040818), M2 (BAY 1088089), and M3 (BAY 1088090)
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tlast): AUC from zero to the last data point for BAY 94-8862 and its metabolites M1 (BAY 1040818), M2 (BAY 1088089), and M3 (BAY 1088090)
    date_rangeTime Frame:
    Pre-dose and up to 72 h post-dose
    enhanced_encryption
    Safety Issue:
    No
  • HR: Heart rate
    date_rangeTime Frame:
    Approximately 6 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • BP: Blood pressure
    date_rangeTime Frame:
    Approximately 6 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately 6 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Erythromycin plasma concentrations
    date_rangeTime Frame:
    Single complicance check on -01d00h in Treatment B only
    enhanced_encryption
    Safety Issue:
    No

Trial design

Randomized, non-blinded, non-placebo-controlled, two-fold cross-over study to investigate the influence of multiple doses of 500 mg erythromycin tid on the safety, tolerability, pharmacodynamics, and pharmacokinetics of a single oral dose of 1.25 mg BAY 94-8862 in comparison to a single dose of 1.25 mg of BAY 94-8862 alone in healthy male subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
2