Trial Condition(s):

Heart Failure

Dose proportionality study with BAY94-8862 IR (immediate release) tablets

Bayer Identifier:

15481

ClinicalTrials.gov Identifier:

NCT01687920

EudraCT Number:

2012-003055-10

Study Completed

Trial Purpose

This study should estimate the dose proportionality of BAY94-8862 IR tablets.

Inclusion Criteria
- Healthy male subject
- Age: 18 to 46 years (inclusive) at the first screening examination
- Ethnicity: White
- Body mass index (BMI): >= 18 and <= 29.9 kg / m²
Exclusion Criteria
- Clinically relevant findings in the ECG (electrocardiogram) such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec 
- Systolic blood pressure below 100 or above 140 mmHg 
- Diastolic blood pressure below 50 or above 90 mmHg 
- Heart rate below 50 or above 95 beats/ min
- Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2)
- Participation in another clinical study during the preceding 3 months (Last Treatment from previous study to First Treatment of new study)

Trial Summary

Enrollment Goal
25
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteers
Yes

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

CRS Clinical-Research-Services Mönchengladbach GmbH

Mönchengladbach, Germany, 41061

Status
Completed
 

Trial Design