Trial Condition(s):

Clinical Pharmacology

Drug-drug interaction study to investigate the effect of gemfibrozil on finerenone

Bayer Identifier:

15112

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-001260-35

Study Completed

Trial Purpose

The primary objective of the study was to investigate the influence of multiple oral doses of gemfibrozil 600 mg bid on the pharmacokinetics of 10 mg finerenone.
The secondary objective of the study was to assess the safety and tolerability of 10 mg finerenone given as a single oral dose on the background of gemfibrozil in comparison to 10 mg finerenone given alone.

Inclusion Criteria
- Healthy white male subjects between 18 and 45 years (inclusive) of age and a body mass index between 18 and 29.9 kg/m2 (both inclusive)
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
16
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Kerendia (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