Trial Condition(s):

Clinical Pharmacology

BAY94-8862, Rel. Bioavailability and food effect study

Bayer Identifier:

15526

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2011-000036-28

Study Completed

Trial Purpose

Primary objective: To investigate the pharmacokinetics (PK) of BAY 94-8862 after single oral doses of a 1.25 mg immediate release (IR) tablet, a 10 mg IR tablet and four 1.25 mg IR tablets (= 5 mg of BAY 94-8862) in the fasted state in healthy male subjects in a randomized, open-label, 3-fold crossover design.
Secondary objectives: To assess safety and tolerability of BAY 94-8862.

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

Trial Summary

Enrollment Goal
12
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Wuppertal, Germany, 42096

Status
Completed
 

Trial Design