Trial Condition(s):

Clinical Pharmacology

Finerenone mass balance study

Bayer Identifier:

14502

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

Study Completed

Trial Purpose

Primary objectives of the study were:
Part A
• to investigate the bioavailability of a novel formulation, the aqueous solution of finerenone compared to a 10 mg IR tablet in healthy male subjects in order to decide on the use of this formulation versus the alternative option (PEG solution) in Part B of the study.

Part B
• to measure the cumulative amount as well as the time course of drug-related, radiolabeled material excreted in the urine and feces following a single dose of 10 mg [14C]finerenone (oral solution).
• to characterize the metabolite pattern in plasma, urine, and feces and to identify metabolites where possible (the results will be reported under separate cover).
• to quantify total radioactivity in blood and plasma.
• to quantify finerenone and metabolites circulating in plasma, if possible (the results will be reported under separate cover).
Secondary objective of the study was to assess the safety and tolerability of an oral single dose of 10 mg finerenone in healthy subjects.

Inclusion Criteria
- Healthy male subjects, 45 to 65 years (inclusive) of age, body mass index: 18 30 kg/m2
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
12
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

Allschwil, Switzerland, 4123

Status
Completed
 

Trial Design