Trial Condition(s):

Clinical Pharmacology

Investigation of the effect of finerenone on the QTc interval

Bayer Identifier:

15113

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-000191-26

Study Completed

Trial Purpose

Primary objective:
• To rule out an effect (i.e. to demonstrate a lack of effect) of a single 20 mg and 80 mg oral dose of finerenone on manually read QT interval corrected for heart rate (QTc) as compared to placebo
Secondary objectives:
• To assess / validate the sensitivity of the assessment of the QT interval corrected for heart rate (QTc), to characterize the effect of a single oral dose of 400 mg of moxifloxacin on QTc value relative to placebo
• To characterize the effect on HR relative to placebo of single oral doses of 400 mg of moxifloxacin, 20 mg and 80 mg of finerenone
• To characterize the plasma exposure of finerenone and moxifloxacin
• To explore the relationship between moxifloxacin exposure and ECG parameters (QTc and HR)

Inclusion Criteria
- Healthy male or female white subjects between 18 and 55 years of
age
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
60
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

Mannheim, Germany, 68167

Status
Completed
 

Trial Design