Trial Condition(s):

Clinical Pharmacology

BAY94-8862, Single dose titration study

Bayer Identifier:

13782

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2009-011960-12

Study Completed

Trial Purpose

Primary objective: To investigate the safety and tolerability of BAY 94-8862 after single oral doses starting at 1.0 mg administered as a polyethylene glycol based solution in healthy male subjects. While doses up to 40 mg were planned, the maximum dose depended on the safety, tolerability, and pharmacokinetic results of the previous dose step.
Secondary objectives: To investigate the pharmacodynamics and pharmacokinetics of BAY 94-8862.

Inclusion Criteria
- Healthy male white subjects; 18 to 45 years of age; body mass index  between 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 electrocardiogram values, 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 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 which could interfere with the investigational product
 - Concomitant administration of potassium-sparing diuretics, angiotensin-converting enzyme
inhibitors, nonsteroidal anti-inflammatory drugs or potassium supplements
 - History of peptic ulcers or relevant gastro-esophageal reflux disease
 - Subjects testing positive in the drug screening
 - History of substance abuse, including alcohol abuse or dependence
 - 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
45
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

Wuppertal, Germany, 42096

Status
Completed
 

Trial Design