Trial Condition(s):

Clinical Pharmacology

Finerenone/digoxin drug-drug interaction study

Bayer Identifier:

14505

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-004083-38

Study Completed

Trial Purpose

The primary objective of the study was to investigate the influence of a concomitant intake of multiple doses of 20 mg finerenone administered once-daily (od) for 10 days on the steady-state pharmacokinetics of digoxin (0.375 mg od).
The secondary objective was to assess the safety and tolerability of the combined administration of both drugs and to determine the influence of multiple doses of digoxin (0.375 mg od) on the pharmacokinetics of a single dose of 20 mg finerenone.

Inclusion Criteria
- Healthy male subjects, white, age: 18 to 45 years, body  mass index: ≥ 18.0 and ≤ 29.9 kg/m².
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
24
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteers
Yes

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Mannheim, Germany, 68167

Status
Completed
 

Trial Design