Trial Condition(s):

Clinical Pharmacology

Study to investigate the natriuretic effects, safety, tolerability and pharmacokinetics of BAY94-8862

Bayer Identifier:

13786

ClinicalTrials.gov Identifier:

NCT01473108

EudraCT Number:

2010-018500-90

Study Completed

Trial Purpose

Pharmacodynamics, pharmacokinetics, safety, and tolerability will be investigated in this single dose study. In 5 treatment groups, different dosages of BAY94-8862 will be given in healthy male subjects.

Inclusion Criteria
- Healthy male white subjects
 - 18 to 46 years of age
 - Body mass index (BMI): 18 - 29.9 kg/m²
Exclusion Criteria
- Clinically relevant findings in medical history or in the physical examination
 - Systolic blood pressure below 100 or above 140 mmHg
 - Diastolic blood pressure below 50 or above 90 mmHg
 - Heart rate below 45 or above 95 beats / min

Trial Summary

Enrollment Goal
67
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

Neuss, Germany, 41460

Status
Completed
 

Trial Design