Trial Condition(s):

Clinical Pharmacology

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

Bayer Identifier:

16541

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-002088-13

Study Completed

Trial Purpose

The primary objective of this study is
- to investigate the influence of a single oral dose of finerenone 20 mg on the pharmacokinetics of 0.5 mg repaglinide, given as a single oral dose in combination with 20 mg finerenone or 3 h after administration of 20 mg finerenone, in comparison to 0.5 mg repaglinide given alone.
The secondary objective of this study is:
- to investigate the influence of a single oral dose of finerenone 20 mg on the pharmacodynamics (blood glucose concentration), safety and tolerability of 0.5 mg repaglinide, given as a single oral dose in combination with 20 mg finerenone or 3 h after administration of 20 mg finerenone, in comparison to 0.5 mg repaglinide given alone.

Inclusion Criteria
- Healthy white male subjects aged between 18 and 45 years (inclusive) with a body mass index ≥18 and ≤29.9 kg/m².
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
29
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Wuppertal, Germany, 42113

Status
Completed
 

Trial Design