Study 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

Inclusion Criteria
- Healthy male white subjects; 18 to 46 years of age; body mass index ≥18 and ≤29.9 kg/m*2
Exclusion Criteria
- 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

Trial Dates

April 2012 - August 2012

Phase

Phase 1

Could I Receive a placebo

Products

Finerenone (BAY94-8862)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
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))
Time Frame:
Pre-dose and up to 72 h post-dose
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))
Time Frame:
Pre-dose and up to 72 h post-dose
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)
Time Frame:
Pre-dose and up to 72 h post-dose
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)
Time Frame:
Pre-dose and up to 72 h post-dose
Safety Issue:
No
MRT: Mean residence time for BAY 94-8862 and its metabolites M1 (BAY 1040818), M2 (BAY 1088089), and M3 (BAY 1088090)
Time Frame:
Pre-dose and up to 72 h post-dose
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)
Time Frame:
Pre-dose and up to 72 h post-dose
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)
Time Frame:
Pre-dose and up to 72 h post-dose
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)
Time Frame:
Pre-dose and up to 72 h post-dose
Safety Issue:
No
HR: Heart rate
Time Frame:
Approximately 6 weeks
Safety Issue:
Yes
BP: Blood pressure
Time Frame:
Approximately 6 weeks
Safety Issue:
Yes
Number of participants with adverse events
Time Frame:
Approximately 6 weeks
Safety Issue:
Yes
Erythromycin plasma concentrations
Time Frame:
Single complicance check on -01d00h in Treatment B only
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