Trial Condition(s):

Clinical Pharmacology

Absolute bioavailability study

Bayer Identifier:

16535

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-000752-28

Study Completed

Trial Purpose

The objectives of Part 1 with intravenous finerenone doses including 0.25 mg, 0.5 mg and 1.0 mg infused over 1 h were to investigate the safety, tolerability and pharmacokinetics of these treatments and to select an appropriate intravenous dose for Part 2.
The primary objective of Part 2 of this study, performed in a randomized, non-blinded, non-placebo controlled 2-way crossover design in 16 healthy male subjects, was to evaluate the absolute bioavailability of a single oral dose of a 5 mg IR tablet of finerenone in comparison to an intravenous infusion of 1 mg over 1 h (iv dose as planned and confirmed by results of Part 1) and to characterize the pharmacokinetics of finerenone after intravenous administration. The secondary objectives of Part 2 were to investigate the safety and tolerability.

Inclusion Criteria
- Healthy male white subjects between 18 and 46 years of age (inclusive) and a body mass index ≥ 18 and ≤ 29.9 kg/m^2
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
28
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

Mönchengladbach, Germany, 41061

Status
Completed
 

Trial Design