Trial Condition(s):

Clinical Pharmacology

Drug-drug interaction study with midazolam

Bayer Identifier:

15111

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2016-001844-21

Study Completed

Trial Purpose

The primary objective of the study was to assess the influence of multiple doses of 20 mg finerenone administered once daily for 10 days on the pharmacokinetics of a single oral dose of 7.5 mg midazolam.
The secondary objective of the study was to assess the influence of multiple doses of 20 mg finerenone administered once daily for 10 days on the safety and tolerability of a single oral dose of midazolam.

Inclusion Criteria
- Healthy male subjects between 18 and 45 years of age (inclusive)
and with a body mass index ≥18 and ≤29.9 kg/m^2
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
31
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

Berlin, Germany, 13353

Status
Completed
 

Trial Design