Trial Condition(s):

Clinical Pharmacology

Single/multiple dose escalation study in Japanese subjects

Bayer Identifier:

15171

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The primary objective
•To investigate the safety and tolerability of BAY 94-8862 after single and multiple oral doses of 10 mg BID, 20 mg BID and 40 mg OD administered as 10 mg IR tablets in Japanese healthy adult male subjects
The secondary objective
•To investigate the pharmacodynamics and pharmacokinetics of BAY 94-8862 in Japanese healthy adult male subjects

Inclusion Criteria
- Japanese healthy adult male subjects, 20 to 45 years of age, with body mass index between 17.6 to 26.4 kg/m^2 inclusive
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
36
Trial Dates
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Phase
1
Could I receive a placebo?
Yes
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Kagoshima, Japan, 890-0081

Status
Completed
 

Trial Design