Trial Condition(s):

Clinical Pharmacology

BAY94-8862, Age and Gender Study

Bayer Identifier:

14508

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2010-023874-38

Study Completed

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

Inclusion Criteria
- 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).
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
 - 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
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Phase
1
Could I receive a placebo?
Yes
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Köln, Germany, 51063

Status
Completed
 

Trial Design