Study Completed

Clinical Pharmacology

Bayer Identifier:

13784

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2010-019192-30

EU CT Number:

Not Available

BAY94-8862,Relative bioavailability and food effect study

Trial purpose

Primary objective: To investigate pharmacokinetics of BAY 94-8862 after single oral doses of 10 mg polyethylene glycol solution, 10 mg immediate release (IR) tablet and eight 10 mg IR tablets (= 80 mg of BAY 94-8862) in the fasted state and 10 mg IR tablet with a high-fat, high-calorie breakfast in healthy male subjects in a randomized, open-label, four-fold crossover design.
Secondary objectives: To assess safety and tolerability of BAY 94-8862.

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 electrocardiography, physical 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, 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
- Subjects testing positive in the drug screening or alcohol breath test
- Subject testing positive for human immunodeficiency virus type 1 and 2 antibody, hepatitis B surface antigen or hepatitis C virus antibody
- Serum potassium level greater than equal to 5.0 mmol/L, serum sodium level less than equal to 130 mmol/L

Trial summary

Enrollment Goal

Trial Dates

May 2010 - July 2010

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 plasma concentration versus time curve from zero to infinity after single dose)
Time Frame:
Pre-dose and 48 h post-dose
Safety Issue:
No
AUC/D (AUC divided by dose)
Time Frame:
Pre-dose and 48 h post-dose
Safety Issue:
No
Cmax (Maximum drug concentration in plasma after single dose administration)
Time Frame:
Pre-dose and 48 h post-dose
Safety Issue:
No
Cmax/D (Maximum drug concentration in plasma after single dose administration)
Time Frame:
Pre-dose and 48 h post-dose
Safety Issue:
No

Secondary Outcome

AUCnorm (Area under the curve divided by dose per body weight)
Time Frame:
Pre-dose and 48 h post-dose
Safety Issue:
No
Cmax,norm (Maximum drug concentration in plasma after single dose administration divided by dose per body weight)
Time Frame:
Pre-dose and 48 h post-dose
Safety Issue:
No
tmax (Time to reach maximum drug concentration in plasma after single dose)
Time Frame:
Pre-dose and 48 h post-dose
Safety Issue:
No
t½ (Half-life associated with the terminal slope)
Time Frame:
Pre-dose and 48 h post-dose
Safety Issue:
No
MRT (Mean residence time)
Time Frame:
Pre-dose and 48 h post-dose
Safety Issue:
No
CL/f (Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance))
Time Frame:
Pre-dose and 48 h post-dose
Safety Issue:
No
Vz/f (Apparent volume of distribution during terminal phase after oral administration)
Time Frame:
Pre-dose and 48 h post-dose
Safety Issue:
No
AUC(0-tn) (AUC from zero to the last data point)
Time Frame:
Pre-dose and 48 h post-dose
Safety Issue:
No
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
HR (Heart rate)
Time Frame:
Approximately 6 weeks
Safety Issue:
Yes

Trial design

Relative bioavailability study to investigate the pharmacokinetics, safety and tolerability of single oral doses of BAY 94-8862 given as 10 mg IR tablet in comparison to a 10 mg solution and 8 x 10 mg IR tablet in the fasting condition and to investigate the effect of a high fat, high calorie meal on the 10 mg IR tablet in healthy male subjects in a randomized, open-label, four-fold crossover design

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

Randomized

Blinding

Open Label

Assignment

Crossover Assignment

Trial Arms