Trial Condition(s):

Clinical Pharmacology

Asian single dose escalation study

Bayer Identifier:

15528

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The primary objective of the study was
• to investigate the safety and tolerability of BAY94-8862 after single oral doses of 1.25, 10, and 40 mg BAY 94 8862 administered as immediate-release (IR) tablets containing 1.25 mg and 10 mg BAY94-8862, respectively, in Asian (Chinese) healthy male subjects
The secondary objectives of this study was
• to investigate the pharmacokinetics of BAY94-8862 and its 3 metabolites M1 (BAY1040818), M2 (BAY1088089), and M3 (BAY1088090) in Asian (Chinese) healthy male subjects

Inclusion Criteria
- Healthy young male Asian (Chinese) subjects, 21 to 45 years of age, with body mass index between 18.0 and 29.9 kg/m2 inclusive were planned to be enrolled.
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
36
Trial Dates
black-arrow
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

Singapore, Singapore, 529889

Status
Completed
 

Trial Design